UNITED STATESSECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549FORM 10-Q
(Mark One)
x QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE
QUARTERLY PERIOD ENDED SEPTEMBER 30, 2017
¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR
THE TRANSITION PERIOD FROM TO
Commission file number: 1-1136
BRISTOL-MYERS SQUIBB COMPANY(Exact name of registrant as specified in its charter)
Delaware 22-0790350(State or other jurisdiction of
incorporation or organization) (I.R.S. Employer
Identification No.)
345 Park Avenue, New York, N.Y. 10154(Address of principal executive offices) (Zip Code)
(212) 546-4000(Registrant’s telephone number, including area code)
(Former name, former address and former fiscal year, if changed since last report)
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 duringthe preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to the filing requirements for thepast 90 days. Yes x No ¨
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required tobe submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that theregistrant was required to submit and post such files). Yes x No ¨
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer or a smaller reporting company. Seedefinition of “accelerated filer”, “large accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filer x Accelerated filer ¨ Non-accelerated filer ¨ Smaller reporting company ¨ Emerging growth company ¨
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new orrevised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act) Yes ¨ No x
APPLICABLE ONLY TO CORPORATE ISSUERS:
At September 30, 2017 , there were 1,636,699,696 shares outstanding of the Registrant’s $0.10 par value common stock.
BRISTOL-MYERS SQUIBB COMPANYINDEX TO FORM 10-QSEPTEMBER 30, 2017
PART I—FINANCIAL INFORMATION
Item 1. Financial Statements:
Consolidated Statements of Earnings and Comprehensive Income 3Consolidated Balance Sheets 4Consolidated Statements of Cash Flows 5
Notes to Consolidated Financial Statements 6 Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations 21
Item 3. Quantitative and Qualitative Disclosure About Market Risk 34
Item 4. Controls and Procedures 34
PART II—OTHER INFORMATION
Item 1. Legal Proceedings 34
Item 1A. Risk Factors 34
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 34
Item 6. Exhibits 35
Summary of Abbreviated Terms 36Signatures 37
* Indicates brand names of products which are trademarks not owned by BMS. Specific trademark ownership information is included in the Exhibit Index.
PART I—FINANCIAL INFORMATIONItem 1. FINANCIAL STATEMENTS
BRISTOL-MYERS SQUIBB COMPANYCONSOLIDATED STATEMENTS OF EARNINGS
Dollars in Millions, Except Per Share Data(UNAUDITED)
Three Months Ended September 30, Nine Months Ended September 30,
EARNINGS 2017 2016 2017 2016
Net product sales $ 4,862 $ 4,492 $ 14,212 $ 12,888Alliance and other revenues 392 430 1,115 1,296
Total Revenues 5,254 4,922 15,327 14,184 Cost of products sold 1,572 1,305 4,393 3,563Marketing, selling and administrative 1,147 1,144 3,388 3,450Research and development 1,543 1,138 4,490 3,540Other (income)/expense (191) (224) (1,377) (1,198)Total Expenses 4,071 3,363 10,894 9,355
Earnings Before Income Taxes 1,183 1,559 4,433 4,829Provision for Income Taxes 327 344 1,129 1,220Net Earnings 856 1,215 3,304 3,609Net Earnings/(Loss) Attributable to Noncontrolling Interest 11 13 (31) 46Net Earnings Attributable to BMS $ 845 $ 1,202 $ 3,335 $ 3,563
Earnings per Common Share
Basic $ 0.52 $ 0.72 $ 2.02 $ 2.13Diluted $ 0.51 $ 0.72 $ 2.02 $ 2.12
Cash dividends declared per common share $ 0.39 $ 0.38 $ 1.17 $ 1.14
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOMEDollars in Millions
(UNAUDITED)
Three Months Ended September 30, Nine Months Ended September 30,
COMPREHENSIVE INCOME 2017 2016 2017 2016Net Earnings $ 856 $ 1,215 $ 3,304 $ 3,609Other Comprehensive Income/(Loss), net of taxes and reclassifications to earnings:
Derivatives qualifying as cash flow hedges (1) 4 (61) (126)Pension and postretirement benefits 18 72 74 (213)Available-for-sale securities 22 (8) 41 46Foreign currency translation 7 1 28 26
Other Comprehensive Income/(Loss) 46 69 82 (267) Comprehensive Income 902 1,284 3,386 3,342Comprehensive Income/(Loss) Attributable to Noncontrolling Interest 11 13 (31) 46Comprehensive Income Attributable to BMS $ 891 $ 1,271 $ 3,417 $ 3,296
The accompanying notes are an integral part of these consolidated financial statements.
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BRISTOL-MYERS SQUIBB COMPANYCONSOLIDATED BALANCE SHEETS
Dollars in Millions, Except Share and Per Share Data(UNAUDITED)
ASSETSSeptember 30,
2017 December 31,
2016Current Assets:
Cash and cash equivalents $ 4,644 $ 4,237Marketable securities 2,478 2,113Receivables 5,922 5,543Inventories 1,250 1,241Prepaid expenses and other 754 570
Total Current Assets 15,048 13,704Property, plant and equipment 5,014 4,980Goodwill 6,865 6,875Other intangible assets 1,213 1,385Deferred income taxes 2,346 2,996Marketable securities 2,526 2,719Other assets 965 1,048Total Assets $ 33,977 $ 33,707
LIABILITIES Current Liabilities:
Short-term debt obligations $ 1,461 $ 992Accounts payable 1,699 1,664Accrued liabilities 5,418 5,271Deferred income 647 762Income taxes payable 213 152
Total Current Liabilities 9,438 8,841Deferred income 492 547Income taxes payable 996 973Pension and other liabilities 1,155 1,283Long-term debt 6,982 5,716
Total Liabilities 19,063 17,360
Commitments and contingencies (Note 17) EQUITY Bristol-Myers Squibb Company Shareholders’ Equity:
Preferred stock — —Common stock 221 221Capital in excess of par value of stock 1,845 1,725Accumulated other comprehensive loss (2,421) (2,503)Retained earnings 34,141 33,513Less cost of treasury stock (19,003) (16,779)
Total Bristol-Myers Squibb Company Shareholders’ Equity 14,783 16,177Noncontrolling interest 131 170
Total Equity 14,914 16,347Total Liabilities and Equity $ 33,977 $ 33,707
The accompanying notes are an integral part of these consolidated financial statements.
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BRISTOL-MYERS SQUIBB COMPANYCONSOLIDATED STATEMENTS OF CASH FLOWS
Dollars in Millions(UNAUDITED)
Nine Months Ended September 30,
2017 2016Cash Flows From Operating Activities: Net earnings $ 3,304 $ 3,609Adjustments to reconcile net earnings to net cash provided by operating activities:
Depreciation and amortization, net 592 260Deferred income taxes 283 (500)Stock-based compensation 149 149Impairment charges 223 75Pension settlements and amortization 148 122Divestiture gains and royalties (546) (1,082)Asset acquisition charges 510 274Other adjustments 108 (56)
Changes in operating assets and liabilities: Receivables (539) (896)Inventories 7 (107)Accounts payable 63 (142)Deferred income (91) 445Income taxes payable 400 (183)Other (453) (353)
Net Cash Provided by Operating Activities 4,158 1,615Cash Flows From Investing Activities:
Sale and maturities of marketable securities 4,296 3,674Purchase of marketable securities (4,434) (2,248)Capital expenditures (801) (844)Divestiture and other proceeds 526 1,193Acquisition and other payments (672) (311)
Net Cash Provided by/(Used in) Investing Activities (1,085) 1,464Cash Flows From Financing Activities:
Short-term debt obligations, net 1,198 102Issuance of long-term debt 1,488 —Repayment of long-term debt (1,224) —Repurchase of common stock (2,220) (231)Dividends (1,938) (1,912)Other (29) (7)
Net Cash Used in Financing Activities (2,725) (2,048)Effect of Exchange Rates on Cash and Cash Equivalents 59 16Increase in Cash and Cash Equivalents 407 1,047Cash and Cash Equivalents at Beginning of Period 4,237 2,385Cash and Cash Equivalents at End of Period $ 4,644 $ 3,432
The accompanying notes are an integral part of these consolidated financial statements.
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Note 1 . BASIS OF PRESENTATION AND RECENTLY ISSUED ACCOUNTING STANDARDS
Bristol-Myers Squibb Company prepared these unaudited consolidated financial statements following the requirements of the SEC and U.S. GAAP for interimreporting. Under those rules, certain footnotes and other financial information that are normally required for annual financial statements can be condensed oromitted. The Company is responsible for the consolidated financial statements included in this Quarterly Report on Form 10-Q, which include all adjustmentsnecessary for a fair presentation of the financial position at September 30, 2017 and December 31, 2016 , the results of operations for the three and nine monthsended September 30, 2017 and 2016, and cash flows for the nine months ended September 30, 2017 and 2016 . All intercompany balances and transactions havebeen eliminated. These financial statements and the related notes should be read in conjunction with the audited consolidated financial statements for the yearended December 31, 2016 included in the 2016 Form 10-K. Refer to the Summary of Abbreviated Terms at the end of this Quarterly Report on Form 10-Q forterms used throughout the document.
Revenues, expenses, assets and liabilities can vary during each quarter of the year. Accordingly, the results and trends in these unaudited consolidated financialstatements may not be indicative of full year operating results. The preparation of financial statements requires the use of management estimates, judgments andassumptions. The most significant assumptions are estimates used in determining sales rebate and return accruals; legal contingencies; income taxes; determining ifan acquisition or divestiture is a business or an asset; and pension and postretirement benefits. Actual results may differ from estimates.
Certain prior period amounts were reclassified to conform to the current period presentation. The consolidated statements of cash flows previously presentedinterest rate swap contract terminations and issuance of common stock as separate line items within cash flows from financing activities which are now presentedas components of other financing activities. The reclassifications provide a more concise financial statement presentation and additional information is disclosed inthe notes if material.
Recently Adopted Accounting StandardsShare-based Payment TransactionsAmended guidance for share-based payment transactions was adopted in the first quarter of 2017. Net excess tax benefits of $30 million for the nine months endedSeptember 30, 2017 were recognized prospectively as a reduction of tax expense rather than capital in excess of par value of stock. Net excess tax benefits are alsopresented as an operating cash flow rather than a financing cash flow, and cash payments to tax authorities in connection with shares withheld for statutory taxwithholding requirements are presented as a financing cash flow rather than an operating cash flow. The changes in cash flow presentation were appliedretrospectively and increased operating cash flows and decreased financing cash flows by $113 million for the nine months ended September 30, 2017 and $193million for the nine months ended September 30, 2016 .
Income Tax Accounting for Intra-entity Transfers of Assets Other Than InventoryAmended guidance on income tax accounting for intra-entity transfers of assets other than inventory was early adopted in the first quarter of 2017 on a modifiedretrospective approach. The amended guidance requires tax consequences of these transfers be recognized in the period the transfer takes place. Net reductions toprepaid and deferred tax assets pertaining to pre-2017 internal transfers of intellectual property of $787 million were adjusted through retained earnings as acumulative effect of an accounting change which will reduce the annual tax expense by $86 million beginning in 2017. In addition, the tax consequences ofadditional internal transfers of intellectual property that may occur in the future will be included in income tax expense upon transfer and not amortized insubsequent periods.
Recently Issued Accounting StandardsAccounting for Hedging ActivitiesIn August 2017, the FASB issued amended guidance on derivatives and hedging. The amended guidance revises and expands items eligible for hedge accounting,simplifies hedge effectiveness testing and changes the timing of recognition and presentation for certain hedged items. Certain disclosure requirements are alsomodified for hedging activities on a prospective basis. The guidance is effective in 2019 with early adoption permitted on a modified retrospective approach. TheCompany is assessing the potential impact of the new standard.
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Presentation of Net Periodic Pension and Postretirement BenefitsIn March 2017, the FASB issued amended guidance requiring all net periodic benefit components for defined benefit pension and other postretirement plans otherthan service costs to be recorded outside of income from operations (other income). The guidance is effective in 2018 on a retrospective basis. The Companyexpects that annual cost of products sold; marketing, selling and administrative; and research and development expenses will increase by approximately $130million in the aggregate with a corresponding offset in other income.
Revenue from Contracts with CustomersAmended guidance for revenue recognition will be adopted in the first quarter of 2018 using the modified retrospective method with the cumulative effect of thechange recognized in retained earnings. The new guidance referred to as ASC 606 requires an entity to recognize the amount of revenue to which it expects to beentitled for the transfer of promised goods or services to customers and replaces most of the existing revenue recognition standards in U.S. GAAP. A five stepmodel will be utilized to achieve the core principle; (1) identify the customer contract, (2) identify the contract’s performance obligations, (3) determine thetransaction price, (4) allocate the transaction price to the performance obligations and (5) recognize revenue when or as a performance obligation is satisfied.
The Company’s assessment of the new standard’s impact is substantially complete. The timing of recognizing revenue is not expected to change for typical netproduct sales to customers, most existing alliance arrangements as well as royalties and sale-based milestones from out-licensing arrangements. In addition, thetiming of recognizing royalties, sales-based milestones and other forms of contingent consideration resulting from the divestiture of businesses is not expected tochange.
However, transaction prices are no longer required to be fixed or determinable and certain variable consideration might be recognized prior to the occurrence orresolution of the contingent event to the extent it is probable that a significant reversal in the amount of estimated cumulative revenue will not occur. Certainestimated future royalties and termination fees for licensing rights previously reacquired by alliance partners are expected to be recognized as contract assets uponadoption of the new standard. Refer to the Sanofi and Erbitux* Japan arrangements in "Note 3. Alliances" of the 2016 Form 10-K. As a result of the new guidanceand cumulative effect adjustment, revenue and other income is expected to be lower in 2018 by approximately $225 million and $125 million , respectively,compared to what would have been reported under the previous standard.
In addition to the items discussed above, the following recently issued accounting standards have not been adopted. Refer to the 2016 Form 10-K for additionalinformation and their potential impacts.
Accounting Standard Update Effective DateRecognition and Measurement of Financial Assets and Liabilities January 1, 2018Definition of a Business January 1, 2018Leases January 1, 2019Financial Instruments - Measurement of Credit Losses January 1, 2020Goodwill Impairment Testing January 1, 2020
Note 2 . BUSINESS SEGMENT INFORMATION
BMS operates in a single segment engaged in the discovery, development, licensing, manufacturing, marketing, distribution and sale of innovative medicines thathelp patients prevail over serious diseases. A global research and development organization and supply chain organization are responsible for the discovery,development, manufacturing and supply of products. Regional commercial organizations market, distribute and sell the products. The business is also supported byglobal corporate staff functions. The determination of a single segment is consistent with the financial information regularly reviewed by the chief executive officerfor purposes of evaluating performance, allocating resources, setting incentive compensation targets and planning and forecasting future periods.Product revenues and the composition of total revenues were as follows:
Three Months Ended September 30, Nine Months Ended September 30,
Dollars in Millions 2017 2016 2017 2016Prioritized Brands
Opdivo $ 1,265 $ 920 $ 3,587 $ 2,464Eliquis 1,232 884 3,509 2,395Orencia 632 572 1,817 1,640Sprycel 509 472 1,478 1,330Yervoy 323 285 975 789Empliciti 60 41 168 103
Established Brands Hepatitis C Franchise 73 379 347 1,352Baraclude 264 306 819 896Sustiva Franchise 183 275 555 819Reyataz Franchise 174 238 555 706Other Brands 539 550 1,517 1,690Total Revenues $ 5,254 $ 4,922 $ 15,327 $ 14,184
Net product sales $ 4,862 $ 4,492 $ 14,212 $ 12,888
Alliance revenues 334 402 957 1,229Other revenues 58 28 158 67
Total Revenues $ 5,254 $ 4,922 $ 15,327 $ 14,184
Note 3 . ALLIANCES
BMS enters into collaboration arrangements with third parties for the development and commercialization of certain products. Although each of thesearrangements is unique in nature, both parties are active participants in the operating activities of the collaboration and are exposed to significant risks and rewardsdepending on the commercial success of the activities. BMS may either in-license intellectual property owned by the other party or out-license its intellectualproperty to the other party. These arrangements also typically include research, development, manufacturing and/or commercial activities and can cover a singleinvestigational compound or commercial product or multiple compounds and/or products in various life cycle stages. The rights and obligations of the parties canbe global or limited to geographic regions. We refer to these collaborations as alliances and our partners as alliance partners. Products sold through alliancearrangements in certain markets include Opdivo , Eliquis , Orencia , Sprycel , Yervoy , Empliciti , Sustiva ( Atripla* ) and certain other brands.
Selected financial information pertaining to our alliances was as follows, including net product sales when BMS is the principal in the third-party customer sale forproducts subject to the alliance. Expenses summarized below do not include all amounts attributed to the activities for the products in the alliance, but only thepayments between the alliance partners or the related amortization if the payments were deferred or capitalized.
Three Months Ended September 30, Nine Months Ended September 30,
Dollars in Millions 2017 2016 2017 2016
Revenues from alliances: Net product sales $ 1,764 $ 1,465 $ 5,045 $ 4,031Alliance revenues 334 402 957 1,229Total Revenues $ 2,098 $ 1,867 $ 6,002 $ 5,260
Payments to/(from) alliance partners: Cost of products sold $ 678 $ 572 $ 1,969 $ 1,543Marketing, selling and administrative (16) (3) (39) (10)Research and development (12) (7) (6) 23Other (income)/expense (151) (160) (545) (864) Noncontrolling interest, pretax 4 3 9 13
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Selected Alliance Balance Sheet information:
Dollars in MillionsSeptember 30,
2017 December 31,
2016Receivables - from alliance partners $ 878 $ 903Accounts payable - to alliance partners 634 555Deferred income from alliances (a) 1,060 1,194(a) Includes unamortized upfront, milestone and other licensing proceeds, revenue deferrals attributed to Atripla* and undelivered elements of diabetes business divestiture proceeds.
Amortization of deferred income (primarily related to alliances) was $59 million and $193 million for the nine months ended September 30, 2017 and 2016 , respectively.
Specific information pertaining to each of our significant alliances is discussed in our 2016 Form 10-K, including their nature and purpose, the significant rightsand obligations of the parties and specific accounting policy elections. Significant developments and updates related to alliances during the nine months endedSeptember 30, 2017 are set forth below.
AstraZenecaBMS received $100 million from AstraZeneca as additional contingent consideration for the diabetes business divestiture upon achievement of a regulatoryapproval milestone in the first quarter of 2017 (included in other income).
F-Star AlphaIn the first quarter of 2017, BMS discontinued development of FS102 (an anti-HER2 antibody fragment) which was in Phase I development for the treatment ofbreast and gastric cancer. BMS will not exercise its option to purchase F-Star Alpha which was previously consolidated by BMS as a variable interest entity. As aresult, an IPRD charge of $75 million was included in R&D expense and attributed to noncontrolling interest in the first quarter of 2017.
Note 4 . ACQUISITIONS, DIVESTITURES AND LICENSING ARRANGEMENTS
AcquisitionsIFMIn the third quarter of 2017, BMS acquired all of the outstanding shares of IFM, a private biotechnology company focused on developing therapies that modulatenovel targets in the innate immune system to treat cancer, autoimmunity and inflammatory diseases. The acquisition provides BMS with full rights to IFM'spreclinical STING and NLRP3 agonist programs focused on enhancing the innate immune response for treating cancer. The consideration includes an upfrontpayment of $300 million and contingent development, regulatory and sales-based milestone payments of up to $1.0 billion for the first product from each of thetwo programs and additional contingent milestone payments of up to $555 million for any subsequent products from these programs. No significant IFM processeswere acquired, therefore the transaction was accounted for as an asset acquisition because IFM was determined not to be a business as that term is defined in ASC805 - Business Combinations. BMS also paid $25 million for certain negotiation rights to collaborate, license or acquire an NLRP3 antagonist program from anewly formed entity established by the former shareholders of IFM. The transactions resulted in $310 million of R&D expense and $15 million of deferred taxassets for net operating losses and tax credit carryforwards.
FlexusIn the second quarter of 2017, a $ 100 million milestone was achieved and paid to former stockholders of Flexus as additional contingent consideration followingthe commencement of a Phase II clinical study of an anti-cancer IDO inhibitor. The additional consideration was included in R&D expense as the Flexusacquisition in 2015 was accounted for as an asset acquisition.
CardioxylIn the second quarter of 2017, a $100 million milestone was achieved and paid to former stockholders of Cardioxyl as additional contingent considerationfollowing the commencement of a Phase II clinical study of a cardiovascular Nitroxyl Donor. The additional consideration was included in R&D expense as theCardioxyl acquisition in 2015 was accounted for as an asset acquisition.
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DivestituresSK BiotekIn the second quarter of 2017, BMS agreed to sell its small molecule active pharmaceutical ingredient manufacturing operations in Swords, Ireland to SK Biotek.The divestiture includes the transfer of the facility, the majority of employees at the site, inventories and certain third-party contract manufacturing obligations. Thepurchase price is expected to be approximately $140 million subject to inventory levels on the date of closing. The transaction is expected to close in the fourthquarter of 2017 subject to SK Biotek's receipt of certain environmental permits and other customary closing conditions and will be accounted for as a sale of abusiness. Net assets of approximately $140 million were accounted for as held-for-sale as of September 30, 2017 , consisting primarily of inventories and property,plant and equipment, and were included in prepaid expenses and other. The assets were reduced to their estimated relative fair value after considering the purchaseprice resulting in an impairment charge of $128 million that was included in cost of products sold in the nine months ended September 30, 2017. SK Biotek willprovide certain manufacturing services for BMS through 2022. Revenues and pretax earnings related to this operation were not material in 2017 and 2016(excluding the impairment charge).
Licensing ArrangementsHalozymeIn the third quarter of 2017, BMS and Halozyme announced a global collaboration and license agreement to develop subcutaneously administered BMS IOmedicines using Halozyme's ENHANZE* drug-delivery technology. This technology may allow for more rapid delivery of large volume injectable medications,such as medications that are currently delivered intravenously, through subcutaneous delivery. BMS agreed to pay $105 million to Halozyme for access to thetechnology which will be included in R&D expense in the fourth quarter of 2017. BMS has designated multiple IO targets, including PD-1, to develop using theENHANZE* technology and has an option to select additional targets within five years from the effective date up to a maximum of 11 targets. BMS may pay up to$160 million upon achievement of contingent development, regulatory and sales-based milestone events for each of the nominated collaboration targets, additionalmilestone payments for combination products and future royalties on sales of products using the ENHANZE* technology. The agreement is subject to obtainingcustomary regulatory and antitrust approvals.
CytomXIn the second quarter of 2017, BMS expanded its strategic collaboration with CytomX to discover novel therapies using CytomX’s proprietary Probody platform.As part of the original May 2014 collaboration to discover, develop and commercialize Probody therapeutics, BMS selected four oncology targets, includingCTLA-4. Pursuant to the expanded agreement, CytomX will grant BMS exclusive worldwide rights to develop and commercialize Probody therapeutics for up toeight additional targets. BMS paid CytomX $75 million for the rights to the initial four targets which was expensed as R&D prior to 2017. BMS paid $200 millionto CytomX for access to the additional targets which was included in R&D expense in the second quarter of 2017. BMS will also reimburse CytomX for certainresearch costs over the collaboration period, pay up to $448 million upon achievement of contingent development, regulatory and sales milestone events for eachcollaboration target and future royalties if a product is approved and commercialized.
BiogenIn the second quarter of 2017, BMS out-licensed to Biogen exclusive rights to develop and commercialize BMS-986168, an anti-eTau compound in developmentfor Progressive Supranuclear Palsy. Biogen paid $300 million to BMS which was included in other income in the second quarter of 2017 as BMS has no furtherperformance obligations as part of the agreement. BMS is also entitled to contingent development, regulatory and sales based milestone payments of up to $410million if achieved as well as future royalties if the product is ultimately approved and commercialized. BMS originally acquired the rights to this compound in2014 through its acquisition of iPierian. Biogen assumed all of BMS’s remaining obligations to the former stockholders of iPierian.
RocheIn the second quarter of 2017, BMS out-licensed to Roche exclusive rights to develop and commercialize BMS-986089, an anti-myostatin adnectin in developmentfor Duchenne Muscular Dystrophy. Roche paid $170 million to BMS which was included in other income in the second quarter of 2017 as BMS has no furtherperformance obligations as part of the agreement. BMS will also be entitled to contingent development and regulatory milestone payments of up to $205 million ifachieved and future royalties if the product is ultimately approved and commercialized.
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Note 5 . OTHER (INCOME)/EXPENSE
Three Months Ended September 30, Nine Months Ended September 30,
Dollars in Millions 2017 2016 2017 2016Interest expense $ 48 $ 42 $ 145 $ 127Investment income (37) (32) (104) (81)Provision for restructuring 28 19 207 41Litigation and other settlements (a) — (1) (489) 48Equity in net income of affiliates (21) (19) (59) (65)Divestiture (gains)/losses 1 (21) (126) (574)Royalties and licensing income (b) (209) (158) (1,093) (579)Transition and other service fees (12) (57) (32) (184)Pension charges 22 19 91 66Intangible asset impairments — — — 15Equity investment impairment — — — 45Loss on debt redemption — — 109 —Other (11) (16) (26) (57)Other (income)/expense $ (191) $ (224) $ (1,377) $ (1,198)
(a) Includes BMS's share of a patent-infringement litigation settlement of $481 million related to Merck's PD-1 antibody Keytruda* in the nine months ended September 30, 2017 .(b) Includes upfront licensing fees of $470 million from Biogen and Roche in the nine months ended September 30, 2017 .
Note 6 . RESTRUCTURING
In October 2016, the Company announced a restructuring plan to evolve and streamline its operating model and expects to incur charges in connection withemployee workforce reductions and early site exits. The majority of the charges are expected to be incurred through 2020, range between $1.5 billion to $2.0billion and consist of employee termination benefit costs, contract termination costs, plant and equipment accelerated depreciation and impairment charges andother site shutdown costs. Cash outlays in connection with these actions are expected to be approximately 40% to 50% of the total charges. Charges of $631million have been recognized for these actions since the announcement ( $82 million and $534 million for the three and nine months ended September 30, 2017 ,respectively). These charges include an impairment charge for the manufacturing operations in Swords, Ireland discussed in "—Note 4 . Acquisitions, Divestituresand Licensing Arrangements." Restructuring charges are recognized upon meeting certain criteria, including finalization of committed plans, reliable estimates anddiscussions with local works councils in certain markets.
Other restructuring charges recognized prior to the above actions were primarily related to specialty care transformation initiatives designed to create a moresimplified organization across all functions and geographic markets. In addition, accelerated depreciation and other charges were incurred in connection with theexpected early exits of a manufacturing site in Ireland and R&D site in the U.S.
Employee workforce reductions were approximately 1,200 and 500 for the nine months ended September 30, 2017 and 2016 , respectively, across all geographicregions for manufacturing, marketing, selling, administrative and R&D personnel.
The following tables summarize the charges and activity related to the restructuring actions:
Three Months Ended September 30, Nine Months Ended September 30,
Dollars in Millions 2017 2016 2017 2016Employee termination costs $ 18 $ 17 $ 190 $ 32Other termination costs 10 2 17 9Provision for restructuring 28 19 207 41Accelerated depreciation 64 15 216 42Asset impairments 1 — 144 —Other shutdown costs — 6 3 13
Total charges $ 93 $ 40 $ 570 $ 96
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Three Months Ended September 30, Nine Months Ended September 30,
Dollars in Millions 2017 2016 2017 2016Cost of products sold $ 1 $ 7 $ 131 $ 15Research and development 64 14 232 40Other (income)/expense 28 19 207 41Total charges $ 93 $ 40 $ 570 $ 96
Nine Months Ended September 30,
Dollars in Millions 2017 2016Liability at January 1 $ 114 $ 125Charges 233 48Change in estimates (26) (7)Provision for restructuring 207 41Foreign currency translation 17 2Spending (179) (88)Liability at September 30 $ 159 $ 80
Note 7 . INCOME TAXES
Three Months Ended September 30, Nine Months Ended September 30,
Dollars in Millions 2017 2016 2017 2016
Earnings Before Income Taxes $ 1,183 $ 1,559 $ 4,433 $ 4,829Provision for Income Taxes 327 344 1,129 1,220Effective Tax Rate 27.6% 22.1% 25.5% 25.3%
The effective tax rate is lower than the U.S. statutory rate of 35% which is primarily attributable to undistributed earnings of certain foreign subsidiaries in low taxjurisdictions that have been considered or are expected to be indefinitely reinvested offshore. These undistributed earnings primarily relate to operations inSwitzerland, Ireland and Puerto Rico. If these undistributed earnings are repatriated to the U.S. in the future, or if it were determined that such earnings are to beremitted in the foreseeable future, additional tax provisions would be required. Due to complexities in the tax laws and assumptions that would have to be made, itis not practicable to estimate the amounts of income taxes that would have to be provided. Reforms to U.S. tax laws related to foreign earnings have been proposedand if adopted, may increase taxes, which could reduce the results of operations and cash flows. BMS operates under a favorable tax grant in Puerto Rico notscheduled to expire prior to 2023.
Jurisdictional tax rates and other tax impacts attributed to R&D charges, divestiture transactions and other discrete pretax items increased the effective tax rate by3.7% and 3.1% in the nine months ended September 30, 2017 and 2016 , respectively, including non-deductible R&D asset acquisition charges and goodwillallocated to business divestitures. The tax impact for discrete items are reflected immediately and are not considered in estimating the annual effective tax rate.
The adoption of the amended guidance for intra-entity transfers of assets other than inventory and share-based payment transactions reduced the effective tax rateby 2.1% in the nine months ended September 30, 2017 . Refer to "—Note 1 . Basis of Presentation and Recently Issued Accounting Standards" for additionalinformation.
BMS is currently under examination by a number of tax authorities which have proposed or are considering proposing material adjustments to tax positions forissues such as transfer pricing, certain tax credits and the deductibility of certain expenses. It is reasonably possible that new issues will be raised by tax authoritieswhich may require adjustments to the amount of unrecognized tax benefits; however, an estimate of such adjustments cannot reasonably be made at this time.
It is also reasonably possible that the total amount of unrecognized tax benefits at September 30, 2017 could decrease in the range of approximately $255 million to$315 million in the next twelve months as a result of the settlement of certain tax audits and other events. The expected change in unrecognized tax benefits mayresult in the payment of additional taxes, adjustment of certain deferred taxes and/or recognition of tax benefits.
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Note 8 . EARNINGS PER SHARE
Three Months Ended September 30, Nine Months Ended September 30,
Amounts in Millions, Except Per Share Data 2017 2016 2017 2016Net Earnings Attributable to BMS used for Basic and Diluted EPS Calculation $ 845 $ 1,202 $ 3,335 $ 3,563 Weighted-average common shares outstanding – basic 1,639 1,671 1,648 1,670Incremental shares attributable to share-based compensation plans 6 8 7 9Weighted-average common shares outstanding – diluted 1,645 1,679 1,655 1,679
Earnings per Common Share:
Basic $ 0.52 $ 0.72 $ 2.02 $ 2.13Diluted $ 0.51 $ 0.72 $ 2.02 $ 2.12
Note 9 . FINANCIAL INSTRUMENTS AND FAIR VALUE MEASUREMENTS
Financial assets and liabilities measured at fair value on a recurring basis are summarized below:
September 30, 2017 December 31, 2016
Dollars in Millions Level 1 Level 2 Level 1 Level 2Cash and cash equivalents - Money market and other securities $ — $ 3,915 $ — $ 3,532Marketable securities:
Certificates of deposit — 176 — 27Commercial paper — 977 — 750Corporate debt securities — 3,725 — 3,947Equity funds — 119 — 101Fixed income funds — 7 — 7
Derivative assets — 31 — 75Equity investments 90 — 24 —Derivative liabilities — (63) — (30)
As further described in "Note 9. Financial Instruments and Fair Value Measurements" in our 2016 Form 10-K, our fair value estimates use inputs that are either (1)quoted prices for identical assets or liabilities in active markets (Level 1 inputs), (2) observable prices for similar assets or liabilities in active markets or foridentical or similar assets or liabilities in markets that are not active (Level 2 inputs) or (3) unobservable inputs (Level 3 inputs). There were no Level 3 financialassets or liabilities as of September 30, 2017 and December 31, 2016 .
Available-for-sale Securities
The following table summarizes available-for-sale securities:
September 30, 2017 December 31, 2016
Dollars in Millions Amortized Cost
Gross Unrealized
Amortized Cost
Gross Unrealized Gains Losses Fair Value Gains Losses Fair Value
Certificates of deposit $ 176 $ — $ — $ 176 $ 27 $ — $ — $ 27Commercial paper 977 — — 977 750 — — 750Corporate debt securities 3,713 15 (3) 3,725 3,945 10 (8) 3,947Equity investments 57 34 (1) 90 31 — (7) 24
$ 4,923 $ 49 $ (4) $ 4,968 $ 4,753 $ 10 $ (15) $ 4,748
Financial assets measured using the fair value option Equity and fixed incomefunds (a) 126 108
Total $ 5,094 $ 4,856
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Dollars in MillionsSeptember 30,
2017 December 31,
2016Current marketable securities $ 2,478 $ 2,113Non-current marketable securities (b) 2,526 2,719Other assets (c) 90 24
Total $ 5,094 $ 4,856
(a) The fair value option for financial assets was elected for investments in equity and fixed income funds and are included in current marketable securities.(b) All non-current marketable securities mature within five years as of September 30, 2017 and December 31, 2016 .(c) Includes equity investments.
Qualifying Hedges and Non-Qualifying Derivatives
The following table summarizes the fair value of outstanding derivatives:
September 30, 2017 December 31, 2016
Asset (a) Liability (b) Asset (a) Liability (b)
Dollars in Millions Notional Fair Value Notional Fair Value Notional Fair Value Notional Fair Value
Derivatives designated as hedging instruments: Interest rate swap contracts $ — $ — $ 755 $ (3) $ 750 $ 1 $ 755 $ (3)Forward starting interest rate swap contracts — — — — 500 8 250 (11)Foreign currency forward contracts 1,351 25 548 (28) 967 66 198 (9)
Derivatives not designated as hedging instruments:
Foreign currency forward contracts 322 6 1,183 (32) 106 — 360 (7)
(a) Included in prepaid expenses and other and other assets.(b) Included in accrued liabilities and pension and other liabilities.
Cash Flow Hedges — The notional amount of outstanding foreign currency forward contracts was primarily attributed to the euro ( $2.2 billion ) and Japanese yen( $586 million ) at September 30, 2017 . BMS terminated forward starting interest rate swap contracts in the first quarter of 2017 with an aggregate notional valueof $750 million . The proceeds and related gain were not material.
Net Investment Hedges — Non-U.S. dollar borrowings of €950 million ( $1.1 billion ) are designated to hedge euro currency exposures of the net investment incertain foreign affiliates.
Fair Value Hedges — The notional amount of fixed-to-floating interest rate swap contracts terminated was $500 million in 2016 generating proceeds of $43 million(including accrued interest).
Debt Obligations
Short-term debt obligations include:
Dollars in MillionsSeptember 30,
2017 December 31,
2016
Commercial paper $ 799 $ —Bank drafts and short-term borrowings 662 243Current portion of long-term debt — 749
Total $ 1,461 $ 992
The average amount of commercial paper outstanding was $211 million at a weighted-average rate of 1.12% during 2017. The maximum amount of commercialpaper outstanding was $1.0 billion with $799 million outstanding at September 30, 2017 .
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Long-term debt and the current portion of long-term debt include:
Dollars in MillionsSeptember 30,
2017 December 31,
2016Principal Value $ 6,834 $ 6,261Adjustments to Principal Value:
Fair value of interest rate swap contracts (3) (2)Unamortized basis adjustment from swap terminations 234 287Unamortized bond discounts and issuance costs (83) (81)
Total $ 6,982 $ 6,465
Current portion of long-term debt $ — $ 749Long-term debt 6,982 5,716
The fair value of debt was $7.4 billion at September 30, 2017 and $6.9 billion at December 31, 2016 valued using Level 2 inputs. Interest payments were $172million and $140 million for the nine months ended September 30, 2017 and 2016 , respectively, net of amounts related to interest rate swap contracts.
On February 27, 2017, BMS issued senior unsecured notes in a registered public offering. The notes rank equally in right of payment with all of BMS's existingand future senior unsecured indebtedness. BMS may redeem the notes, in whole or in part, at any time prior to maturity at a predetermined redemption price. Thefollowing table summarizes the note issuances:
Dollars in Millions 2017
Principal Value: 1.600% Notes due 2019 $ 7503.250% Notes due 2027 750
Total $ 1,500
Proceeds net of discount and deferred loan issuance costs $ 1,488
During the third quarter of 2017, $750 million of 0.875% Notes matured and were repaid.
During the second quarter of 2017, the Company repurchased certain long-term debt obligations with interest rates ranging from 5.875% to 6.875% . The followingsummarizes the debt repurchase activity:
Dollars in Millions 2017Principal amount $ 337Carrying value 366Debt redemption price 474Loss on debt redemption (a) 109
(a) Including acceleration of debt issuance costs, gain on previously terminated interest rate swap contracts and other related fees.
Note 10 . RECEIVABLES
Dollars in MillionsSeptember 30,
2017 December 31,
2016Trade receivables $ 4,564 $ 3,948Less charge-backs and cash discounts (184) (126)Less bad debt allowances (48) (48)Net trade receivables 4,332 3,774Alliance receivables 878 903Prepaid and refundable income taxes 334 627Other 378 239Receivables $ 5,922 $ 5,543
Non-U.S. receivables sold on a nonrecourse basis were $460 million and $470 million for the nine months ended September 30, 2017 and 2016 , respectively.Receivables from our three largest pharmaceutical wholesalers in the U.S. represented 64% and 66% of total trade receivables at September 30, 2017 andDecember 31, 2016 , respectively.
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Note 11 . INVENTORIES
Dollars in MillionsSeptember 30,
2017 December 31,
2016Finished goods $ 380 $ 310Work in process 956 988Raw and packaging materials 224 264Total inventories $ 1,560 $ 1,562
Inventories $ 1,250 $ 1,241Other assets 310 321
Inventories of $120 million are included in assets held-for-sale as of September 30, 2017 due to the expected transfer of manufacturing operations in Swords,Ireland to SK Biotek. Refer to "—Note 4 . Acquisitions, Divestitures and Licensing Arrangements" for additional information. Other assets include inventoryexpected to remain on hand beyond one year in both periods and inventory pending regulatory approval of $54 million at December 31, 2016 .
Note 12 . PROPERTY, PLANT AND EQUIPMENT
Dollars in MillionsSeptember 30,
2017 December 31,
2016Land $ 105 $ 107Buildings 5,188 4,930Machinery, equipment and fixtures 3,034 3,287Construction in progress 938 849Gross property, plant and equipment 9,265 9,173Less accumulated depreciation (4,251) (4,193)Property, plant and equipment $ 5,014 $ 4,980
Depreciation expense was $509 million and $319 million for the nine months ended September 30, 2017 and 2016 , respectively. Refer to "—Note 4 . Acquisitions,Divestitures and Licensing Arrangements" for additional information relating to the expected transfer of manufacturing operations in Swords, Ireland to SK Biotek.
Note 13 . OTHER INTANGIBLE ASSETS
Dollars in MillionsSeptember 30,
2017 December 31,
2016Licenses $ 564 $ 564Developed technology rights 2,357 2,357Capitalized software 1,339 1,441IPRD 32 107Gross other intangible assets 4,292 4,469Less accumulated amortization (3,079) (3,084)Other intangible assets $ 1,213 $ 1,385
Amortization expense was $142 million and $134 million for the nine months ended September 30, 2017 and 2016 , respectively.
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Note 14 . ACCRUED LIABILITIES
Dollars in Millions September 30,
2017 December 31,
2016Rebates and returns $ 1,901 $ 1,680Employee compensation and benefits 702 818Research and development 689 718Dividends 639 660Branded Prescription Drug Fee 251 234Royalties 249 246Restructuring 121 90Pension and postretirement benefits 41 44Litigation and other settlements 35 43Other 790 738Accrued liabilities $ 5,418 $ 5,271
Note 15 . EQUITY
Common Stock Capital in Excess
of Par Valueof Stock
Accumulated OtherComprehensive Loss
RetainedEarnings
Treasury Stock Noncontrolling
InterestDollars and Shares in Millions Shares Par Value Shares Cost Balance at January 1, 2016 2,208 $ 221 $ 1,459 $ (2,468) $ 31,613 539 $ (16,559) $ 158Net earnings — — — — 3,563 — — 46Other comprehensive loss — — — (267) — — — —Cash dividends declared — — — — (1,904) — — —Stock repurchase program — — — — — 4 (231) —Stock compensation — — 191 — — (6) (5) —Distributions — — — — — — — (36)Balance at September 30, 2016 2,208 $ 221 $ 1,650 $ (2,735) $ 33,272 537 $ (16,795) $ 168 Balance at December 31, 2016 2,208 $ 221 $ 1,725 $ (2,503) $ 33,513 536 $ (16,779) $ 170Accounting change - cumulative effect (a) — — — — (787) — — —Adjusted balance at January 1, 2017 2,208 $ 221 $ 1,725 $ (2,503) $ 32,726 536 $ (16,779) $ 170Net earnings — — — — 3,335 — — 28Other comprehensive income — — — 82 — — — —Cash dividends declared — — — — (1,920) — — —Stock repurchase program — — — — — 40 (2,226) —Stock compensation — — 120 — — (5) 2 —Variable interest entity — — — — — — — (59)Distributions — — — — — — — (8)Balance at September 30, 2017 2,208 $ 221 $ 1,845 $ (2,421) $ 34,141 571 $ (19,003) $ 131
(a) Refer to "—Note 1 . Basis of Presentation and Recently Issued Accounting Standards" for additional information.
BMS has a stock repurchase program authorized by its Board of Directors allowing for repurchases in the open market or through private transactions, includingplans established in accordance with Rule 10b5-1 under the Securities Exchange Act of 1934. The stock repurchase program does not have an expiration date andmay be suspended or discontinued at any time. Treasury stock is recognized at the cost to reacquire the shares. Shares issued from treasury are recognized utilizingthe first-in first-out method. BMS repurchased approximately 3.8 million shares for $226 million during the three months ended September 30, 2017 .
In February 2017, BMS executed accelerated share repurchase agreements to repurchase an aggregate $2 billion of common stock. The agreements were fundedthrough a combination of debt and cash. In February 2017, an initial delivery of approximately 28.7 million shares of BMS common stock, representingapproximately 80% of the notional amount of the agreements, was received by BMS and included in treasury stock. Upon settlement of the accelerated sharerepurchase agreements in May 2017, BMS received an additional 7.8 million shares determined using the volume-weighted average price of BMS common stockduring the term of the transaction.
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The components of other comprehensive income/(loss) were as follows:
2017 2016
Pretax Tax After tax Pretax Tax After taxThree Months Ended September 30, Derivatives qualifying as cash flow hedges:
Unrealized losses $ (28) $ 12 $ (16) $ (14) $ 4 $ (10)Reclassified to net earnings (a) 21 (6) 15 21 (7) 14
Derivatives qualifying as cash flow hedges (7) 6 (1) 7 (3) 4Pension and postretirement benefits:
Actuarial gains/(losses) (5) 2 (3) 72 (26) 46Amortization (b) 19 (11) 8 20 (7) 13Curtailments and settlements (c) 21 (8) 13 19 (6) 13
Pension and postretirement benefits 35 (17) 18 111 (39) 72Available-for-sale securities:
Unrealized gains/(losses) 28 (5) 23 (8) 4 (4)Realized gains (c) (1) — (1) (4) — (4)
Available-for-sale securities 27 (5) 22 (12) 4 (8)Foreign currency translation (10) 17 7 (2) 3 1
$ 45 $ 1 $ 46 $ 104 $ (35) $ 69
Nine Months Ended September 30, Derivatives qualifying as cash flow hedges:
Unrealized losses $ (81) $ 31 $ (50) $ (199) $ 66 $ (133)Reclassified to net earnings (a) (11) — (11) 12 (5) 7
Derivatives qualifying as cash flow hedges (92) 31 (61) (187) 61 (126)Pension and postretirement benefits:
Actuarial losses (40) 17 (23) (453) 160 (293)Amortization (b) 57 (22) 35 56 (19) 37Curtailments and settlements (c) 96 (34) 62 66 (23) 43
Pension and postretirement benefits 113 (39) 74 (331) 118 (213)Available-for-sale securities:
Unrealized gains 49 (7) 42 29 (13) 16Realized (gains)/losses (c) (1) — (1) 30 — 30
Available-for-sale securities 48 (7) 41 59 (13) 46Foreign currency translation (8) 36 28 20 6 26
$ 61 $ 21 $ 82 $ (439) $ 172 $ (267)
(a) Included in cost of products sold(b) Included in cost of products sold, research and development and marketing, selling and administrative expenses(c) Included in other (income)/expense
The accumulated balances related to each component of other comprehensive loss, net of taxes, were as follows:
Dollars in MillionsSeptember 30,
2017 December 31, 2016Derivatives qualifying as cash flow hedges $ (23) $ 38Pension and other postretirement benefits (2,023) (2,097)Available-for-sale securities 34 (7)Foreign currency translation (409) (437)Accumulated other comprehensive loss $ (2,421) $ (2,503)
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Note 16 . PENSION AND POSTRETIREMENT BENEFIT PLANS
The net periodic benefit cost/(credit) of defined benefit pension plans includes:
Three Months Ended September 30, Nine Months Ended September 30,
Dollars in Millions 2017 2016 2017 2016Service cost – benefits earned during the year $ 7 $ 6 $ 19 $ 19Interest cost on projected benefit obligation 48 45 142 145Expected return on plan assets (104) (104) (308) (314)Amortization of prior service credits (1) (1) (3) (3)Amortization of net actuarial loss 20 22 61 62Curtailments and settlements 22 19 91 66Special termination benefits — — — 1Net periodic benefit cost/(credit) $ (8) $ (13) $ 2 $ (24)
Pension settlement charges were recognized after determining that the annual lump sum payments will likely exceed the annual interest and service costs for theprimary and certain other U.S. pension plans. The charges included the acceleration of a portion of unrecognized actuarial losses. Non-current pension liabilitieswere $477 million at September 30, 2017 and $600 million at December 31, 2016 . Defined contribution plan expense in the U.S. was $46 million and $49 millionfor the three months ended September 30, 2017 and 2016 , respectively, and $142 million and $141 million for the nine months ended September 30, 2017 and2016 , respectively.
Note 17 . LEGAL PROCEEDINGS AND CONTINGENCIESThe Company and certain of its subsidiaries are involved in various lawsuits, claims, government investigations and other legal proceedings that arise in theordinary course of business. These claims or proceedings can involve various types of parties, including governments, competitors, customers, suppliers, serviceproviders, licensees, employees, or shareholders, among others. The resolution of these matters often develops over a long period of time and expectations canchange as a result of new findings, rulings, appeals or settlement arrangements. The Company recognizes accruals for such contingencies when it is probable that aliability will be incurred and the amount of loss can be reasonably estimated. These matters involve patent infringement, antitrust, securities, pricing, sales andmarketing practices, environmental, commercial, contractual rights, licensing obligations, health and safety matters, consumer fraud, employment matters, productliability and insurance coverage. Legal proceedings that are material or that the Company believes could become material are described below.
Although the Company believes it has substantial defenses in these matters, there can be no assurance that there will not be an increase in the scope of pendingmatters or that any future lawsuits, claims, government investigations or other legal proceedings will not be material. Unless otherwise noted, the Company isunable to assess the outcome of the respective litigation nor is it able to provide an estimated range of potential loss. Furthermore, failure to enforce our patentrights would likely result in substantial decreases in the respective product revenues from generic competition.
INTELLECTUAL PROPERTYPlavix* — AustraliaAs previously disclosed, Sanofi was notified that, in August 2007, GenRx Proprietary Limited (GenRx) obtained regulatory approval of an application forclopidogrel bisulfate 75mg tablets in Australia. GenRx, formerly a subsidiary of Apotex Inc. (Apotex), has since changed its name to Apotex. In August 2007,Apotex filed an application in the Federal Court of Australia (the Federal Court) seeking revocation of Sanofi’s Australian Patent No. 597784 (Case No. NSD 1639of 2007). Sanofi filed counterclaims of infringement and sought an injunction. On September 21, 2007, the Federal Court granted Sanofi’s injunction. A subsidiaryof the Company was subsequently added as a party to the proceedings. In February 2008, a second company, Spirit Pharmaceuticals Pty. Ltd., also filed arevocation suit against the same patent. This case was consolidated with the Apotex case, and a trial occurred in April 2008. On August 12, 2008, the Federal Courtof Australia held that claims of Patent No. 597784 covering clopidogrel bisulfate, hydrochloride, hydrobromide, and taurocholate salts were valid. The FederalCourt also held that the process claims, pharmaceutical composition claims, and claim directed to clopidogrel and its pharmaceutically acceptable salts wereinvalid. The Company and Sanofi filed notices of appeal in the Full Court of the Federal Court of Australia (Full Court) appealing the holding of invalidity of theclaim covering clopidogrel and its pharmaceutically acceptable salts, process claims, and pharmaceutical composition claims which have stayed the FederalCourt’s ruling. Apotex filed a notice of appeal appealing the holding of validity of the clopidogrel bisulfate, hydrochloride, hydrobromide, and taurocholate claims.A hearing on the appeals occurred in February 2009. On September 29, 2009, the Full Court held all of the claims of Patent No. 597784 invalid. In November2009, the Company and Sanofi applied to the High Court of Australia (High Court) for special leave to appeal the judgment of the Full Court. In March 2010, theHigh Court denied the Company and Sanofi’s request to hear the appeal of the Full Court decision. The case has been remanded to the Federal Court for furtherproceedings related to damages sought by Apotex. The Australian government has intervened in this matter and is also seeking damages for alleged lossesexperienced during the period when the injunction was in place. The Company and Apotex have settled the Apotex case, and the case has been dismissed. TheAustralian government's claim is
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still pending and a trial was concluded in September 2017. The Company is expecting a decision in 2018. It is not possible at this time to predict the outcome of theAustralian government’s claim or its impact on the Company.Sprycel - European UnionIn May 2013, Apotex, Actavis Group PTC ehf, Generics [UK] Limited (Mylan) and an unnamed company filed oppositions in the EPO seeking revocation ofEuropean Patent No. 1169038 (the ‘038 patent) covering dasatinib, the active ingredient in Sprycel . The ‘038 patent is scheduled to expire in April 2020(excluding potential term extensions). On January 20, 2016, the Opposition Division of the EPO revoked the ‘038 patent. In May 2016, the Company appealed theEPO’s decision to the EPO Board of Appeal. In February 2017, the EPO Board of Appeal upheld the Opposition Division's decision, and revoked the ‘038 patent.Orphan drug exclusivity and data exclusivity for Sprycel in the EU expired in November 2016. The EPO Board of Appeal's decision does not affect the validity ofour other Sprycel patents within and outside Europe, including different patents that cover the monohydrate form of dasatinib and the use of dasatinib to treat CML.Additionally, in February 2017, the EPO Board of Appeal reversed and remanded an invalidity decision on European Patent No. 1610780 and its claim to the useof dasatinib to treat CML, which the EPO's Opposition Division had revoked in October 2012. The Company intends to take appropriate legal actions to protectSprycel . We may experience a decline in European revenues in the event that generic dasatinib product enters the market.Anti-PD-1 Antibody Patent Oppositions and LitigationIn September 2015, Dana-Farber Cancer Institute (Dana-Farber) filed a complaint in Massachusetts federal court seeking to correct the inventorship of five relatedU.S. patents directed to methods of treating cancer using PD-1 and PD-L1 antibodies. Specifically, Dana-Farber is seeking to add two scientists as inventors tothese patents. In September 2017, Pfizer filed a motion seeking to intervene in this case alleging that one of the scientists identified by Dana-Farber was employedby a company eventually acquired by Pfizer. This motion has not been acted upon by the court.Eliquis Patent LitigationIn February, March and April 2017, twenty-five generic companies sent the Company Paragraph-IV certification letters informing the Company that they hadfiled abbreviated new drug applications (ANDAs) seeking approval of generic versions of Eliquis . As a result, two Eliquis patents listed in the FDA OrangeBook have now been challenged: the composition of matter patent claiming apixaban specifically and a formulation patent. In April 2017, the Company, along withits partner Pfizer, initiated patent lawsuits under the Hatch-Waxman Act against all generic filers in federal district courts in Delaware and West Virginia. InAugust 2017, the United States Patent and Trademark Office granted patent term restoration to the composition of matter patent, thereby restoring the term of the Eliquis composition of matter patent, which is the Company’s basis for projected loss of exclusivity, from February 2023 to November 2026. In September 2017,the Company settled its lawsuit with Teva Pharmaceuticals USA, Inc. and the parties agreed to dismiss the case. The settlement does not impact the Company’sprojected loss of exclusivity for Eliquis .
PRICING, SALES AND PROMOTIONAL PRACTICES LITIGATIONPlavix* State Attorneys General LawsuitsThe Company and certain affiliates of Sanofi are defendants in consumer protection and/or false advertising actions brought by several states relating to the salesand promotion of Plavix* . It is not possible at this time to reasonably assess the outcome of these lawsuits or their potential impact on the Company.
PRODUCT LIABILITY LITIGATIONThe Company is a party to various product liability lawsuits. Plaintiffs in these cases seek damages and other relief on various grounds for alleged personal injuryand economic loss. As previously disclosed, in addition to lawsuits, the Company also faces unfiled claims involving its products.Plavix*As previously disclosed, the Company and certain affiliates of Sanofi are defendants in a number of individual lawsuits in various state and federal courts claimingpersonal injury damage allegedly sustained after using Plavix* . Over 5,000 claims involving injury plaintiffs as well as claims by spouses and/or otherbeneficiaries, have been filed in state and federal courts in various states including California, New Jersey, Delaware and New York. In February 2013, the JudicialPanel on Multidistrict Litigation granted the Company and Sanofi’s motion to establish a multi-district litigation (MDL) to coordinate Federal pretrial proceedingsin Plavix* product liability and related cases in New Jersey Federal Court. Following the United States Supreme Court’s June 2017 reversal of a CaliforniaSupreme Court decision that had held that the California state courts can exercise personal jurisdiction over the claims of non-California residents, over 2,000 out-of-state resident plaintiffs' claims (including spouses and beneficiaries) previously pending in the California state court have been, or are in the process of beingdismissed. Some number of these California non-resident plaintiffs’ claims may be re-filed in federal court. It is not possible at this time to reasonably assess theoutcome of these lawsuits or the potential impact on the Company.
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Byetta*Amylin, a former subsidiary of the Company, and Lilly are co-defendants in product liability litigation related to Byetta*. To date, there are over 500 separatelawsuits pending on behalf of approximately 2,000 active plaintiffs (including pending settlements), which include injury plaintiffs as well as claims by spousesand/or other beneficiaries, in various courts in the U.S. The Company has agreed in principle to resolve over 15 of these claims. The majority of these cases havebeen brought by individuals who allege personal injury sustained after using Byetta* , primarily pancreatic cancer and pancreatitis, and, in some cases, claimingalleged wrongful death. The majority of cases were pending in Federal Court in San Diego in an MDL or in a coordinated proceeding in California Superior Courtin Los Angeles (JCCP). In November 2015, the defendants' motion for summary judgment based on federal preemption was granted in both the MDL and theJCCP. The plaintiffs in the MDL have appealed to the U.S. Court of Appeals for the Ninth Circuit and the JCCP plaintiffs have appealed to the California Court ofAppeal. Amylin has product liability insurance covering a substantial number of claims involving Byetta* and any additional liability to Amylin with respect toByetta* is expected to be shared between the Company and AstraZeneca. It is not possible to reasonably predict the outcome of any lawsuit, claim or proceeding orthe potential impact on the Company.Abilify*The Company and Otsuka are co-defendants in product liability litigation related to Abilify* . Plaintiffs allege Abilify* caused them to engage in compulsivegambling and other impulse control disorders. There have been over 400 cases filed in state and federal courts and several additional cases are pending in Canada.The Judicial Panel on Multidistrict Litigation has consolidated the federal court cases for pretrial purposes in the United States District Court for the NorthernDistrict of Florida.EliquisThe Company and Pfizer are co-defendants in product liability litigation related to Eliquis . Plaintiffs assert claims, including claims for wrongful death, as a resultof bleeding they allege was caused by their use of Eliquis . The majority of these claims are pending in an MDL in the United States District Court for the SouthernDistrict of New York and in state court in Delaware. As of October 2017, there are over 150 cases pending in the MDL and state courts in the United States andone pending in Canada. Over 80 cases have been dismissed with prejudice by the MDL. Plaintiffs have appealed some of the dismissed cases to the Second CircuitCourt of Appeals.
SHAREHOLDER DERIVATIVE LITIGATIONSince December 2015, three shareholder derivative lawsuits were filed in New York state court against certain officers and directors of the Company. The plaintiffsallege, among other things, breaches of fiduciary duty surrounding the Company’s previously disclosed October 2015 civil settlement with the Securities andExchange Commission of alleged Foreign Corrupt Practices Act violations in China in which the Company agreed to a payment of approximately $14.7 million indisgorgement, penalties and interest. As of October 2017, all three of the lawsuits have been dismissed. The Company received a notice of appeal for one of thelawsuits in September 2017.
GOVERNMENT INVESTIGATIONSLike other pharmaceutical companies, the Company and certain of its subsidiaries are subject to extensive regulation by national, state and local governmentagencies in the U.S. and other countries in which BMS operates. As a result, the Company, from time to time, is subject to various governmental inquiries andinvestigations. It is possible that criminal charges, substantial fines and/or civil penalties, could result from government investigations.
ENVIRONMENTAL PROCEEDINGSAs previously reported, the Company is a party to several environmental proceedings and other matters, and is responsible under various state, federal and foreignlaws, including CERCLA, for certain costs of investigating and/or remediating contamination resulting from past industrial activity at the Company’s current orformer sites or at waste disposal or reprocessing facilities operated by third parties.
CERCLA MattersWith respect to CERCLA matters for which the Company is responsible under various state, federal and foreign laws, the Company typically estimates potentialcosts based on information obtained from the U.S. Environmental Protection Agency, or counterpart state or foreign agency and/or studies prepared by independentconsultants, including the total estimated costs for the site and the expected cost-sharing, if any, with other “potentially responsible parties,” and the Companyaccrues liabilities when they are probable and reasonably estimable. The Company estimated its share of future costs for these sites to be $63 million atSeptember 30, 2017 , which represents the sum of best estimates or, where no best estimate can reasonably be made, estimates of the minimal probable amountamong a range of such costs (without taking into account any potential recoveries from other parties). The amount includes the estimated costs for any additionalprobable loss associated with the previously disclosed North Brunswick Township High School Remediation Site.
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Item 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
EXECUTIVE SUMMARY
Bristol-Myers Squibb Company is a global specialty biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that helppatients prevail over serious diseases. Our strategy is to combine the resources, scale and capability of a pharmaceutical company with the speed and focus oninnovation of the biotech industry. Our four strategic priorities are to drive business performance, continue to build a strong franchise in IO, maintain a diversifiedportfolio both within and outside of IO, and continue our disciplined approach to capital allocation, including establishing partnerships and collaborations as anessential component of successfully delivering transformational medicines to patients. Refer to the Summary of Abbreviated Terms at the end of this QuarterlyReport on Form 10-Q for terms used throughout the document.
Our revenues increased by 8% for the nine months ended September 30, 2017 as a result of higher demand for our prioritized brands including Opdivo and Eliquispartially offset by increased competition for established brands, primarily Daklinza . The $0.10 decrease in GAAP EPS was due to higher license, asset acquisitionand restructuring related charges and lower divestiture related income. These items were partially offset by higher revenues, royalties and licensing income and thepatent-infringement litigation settlement related to Merck's PD-1 antibody Keytruda* (pembrolizumab). After adjusting for licensing income, litigation settlements,license and asset acquisition charges and other specified items, non-GAAP EPS increased $0.12 .
Three Months Ended September 30, Nine Months Ended September 30,
Dollars in Millions, except per share data 2017 2016 2017 2016Total Revenues $ 5,254 $ 4,922 $ 15,327 $ 14,184 Diluted Earnings Per Share
GAAP 0.51 0.72 2.02 2.12Non-GAAP 0.75 0.77 2.32 2.20
Our non-GAAP financial measures, including non-GAAP earnings and related EPS information, are adjusted to exclude specified items which represent certaincosts, expenses, gains and losses and other items impacting the comparability of financial results. For a detailed listing of all specified items and furtherinformation and reconciliations of non-GAAP financial measures refer to “—Non-GAAP Financial Measures.”
Puerto Rico UpdateLike many others in the pharmaceutical industry, we have manufacturing and commercial operations in Puerto Rico which were impacted by the recent hurricanes.Our two manufacturing sites sustained some damage but are currently operating at limited capacity. We continue to work to restore to normal operations. Our firstpriority was to ensure the safety and well-being of our employees. We have accounted for 100% of our employees and continue to provide humanitarian aid asneeded. Our business continuity plans have been successful to date despite very challenging conditions with no supply disruption to date. In addition, we do notforesee any product supply issues. Although our financial results for the quarter were not significantly impacted, we will continue to monitor and assess theongoing effects.
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Significant Product and Pipeline Approvals
The following is a summary of significant approvals received in 2017 :
Product Date Approval
Opdivo
September 2017 FDA approval for the treatment of patients with HCC, a type of liver cancer, who have been previously treated withsorafenib.
September 2017 Approval in Japan for the treatment of unresectable advanced or recurrent gastric cancer which has progressed afterchemotherapy, received by our alliance partner, Ono.
August 2017 FDA approval for the treatment of adult and pediatric patients with MSI-H or dMMR mCRC that has progressedfollowing treatment with a fluoropyrimidine, oxaliplatin and irinotecan.
June 2017 EC approval for the treatment of patients with previously treated locally advanced unresectable or metastaticurothelial carcinoma, a type of bladder cancer, in adults after failure of platinum-containing therapy.
April 2017 EC approval for the treatment of SCCHN in adults progressing on or after platinum-based therapy.March 2017 Approval in Japan for the treatment of recurrent or metastatic HNC, received by our alliance partner, Ono.
February 2017 FDA approval for the treatment of patients with previously treated locally advanced or metastatic urothelialcarcinoma, a type of bladder cancer.
Orencia
July 2017EC approval for the treatment of active PsA in adults for whom the response to previous disease-modifyingantirheumatic drug therapy, including methotrexate, has been inadequate, and additional systemic therapy forpsoriatic skin lesions is not required.
July 2017 FDA approval for the treatment of active PsA in adults.
March 2017 FDA approval of a new subcutaneous administration option for use in patients two years of age and older withmoderately to severely active polyarticular JIA.
Yervoy July 2017 FDA approval of an expanded indication for the treatment of unresectable or metastatic melanoma in pediatricpatients.
Hepatitis C Franchise April 2017China FDA approval of the Daklinza and Sunvepra regimen for treatment-naive or experienced patients infectedwith genotype 1b chronic HCV. In addition, Daklinza was approved in China for combination use with otheragents, including sofosbuvir, for adult patients with HCV genotypes 1-6 infection.
Refer to "—Product and Pipeline Developments" for all of the developments in our marketed products and late-stage pipeline in 2017 .
Acquisitions and Licensing ArrangementsAcquisition and licensing transactions allow us to focus our resources behind our growth opportunities that drive the greatest long-term value. We are focused onthe following core therapeutic areas: oncology, including IO, immunoscience, cardiovascular and fibrosis. Significant transactions entered into in 2017 aresummarized below. Refer to "Item 1. Financial Statements—Note 4 . Acquisitions, Divestitures and Licensing Arrangements" for further information.
Halozyme
In the third quarter of 2017, BMS and Halozyme announced a global collaboration and license agreement to develop subcutaneously administered BMS IOmedicines using Halozyme's ENHANZE* drug-delivery technology. This transaction is expected to close in the fourth quarter of 2017 subject to obtainingcustomary regulatory and antitrust approvals.
IFMIn the third quarter of 2017, BMS acquired all of the outstanding shares of IFM, a private biotechnology company focused on developing therapies that modulatenovel targets in the innate immune system to treat cancer, autoimmunity and inflammatory diseases. The acquisition provides BMS with full rights to IFM'spreclinical STING and NLRP3 agonist programs focused on enhancing the innate immune response for treating cancer.
BiogenIn the second quarter of 2017, BMS out-licensed to Biogen exclusive rights to develop and commercialize BMS-986168, an anti-eTau compound in developmentfor Progressive Supranuclear Palsy.
RocheIn the second quarter of 2017, BMS out-licensed to Roche exclusive rights to develop and commercialize BMS-986089, an anti-myostatin adnectin in developmentfor Duchenne Muscular Dystrophy.
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CytomXIn the second quarter of 2017, BMS and CytomX, a biopharmaceutical company developing investigational Probody therapeutics for the treatment of cancer,expanded their strategic collaboration to discover novel therapies that will include up to eight additional targets using CytomX’s proprietary Probody platform.
RESULTS OF OPERATIONS
Regional Revenues
Three Months Ended September 30, Nine Months Ended September 30,
Total Revenues 2017 vs. 2016 Total Revenues 2017 vs. 2016
Dollars in Millions 2017 2016 Total Change Foreign
Exchange (b) 2017 2016 Total Change Foreign
Exchange (b)
United States $ 2,864 $ 2,790 3 % — $ 8,467 $ 8,015 6 % —Europe 1,262 946 33 % 5 % 3,596 2,855 26 % (1)%Rest of the World 970 1,069 (9)% (2)% 2,858 2,922 (2)% (1)%Other (a) 158 117 35 % N/A 406 392 4 % N/ATotal $ 5,254 $ 4,922 7 % 1 % $ 15,327 $ 14,184 8 % (1)%
(a) Other revenues include royalties and alliance-related revenues for products not sold by our regional commercial organizations.(b) Foreign exchange impacts were derived by applying the prior period average currency rates to the current period sales.
U.S. revenues increased in both periods due to higher demand for Eliquis and Opdivo partially offset by lower demand for established brands due to increasedcompetition, primarily Daklinza . Average U.S. net selling prices were approximately 2% higher after charge-backs, rebates and discounts in the nine months endedSeptember 30, 2017 compared to the prior year period. Refer to “—Product Revenues” below for additional information.
Europe revenues increased in both periods due to higher demand for Opdivo and Eliquis partially offset by lower demand for Daklinza due to increasedcompetition .
Rest of the World revenues decreased in both periods due to lower demand for established brands, including Daklinza, due to increased competition and thedivestiture of certain other brands partially offset by higher demand for Opdivo and Eliquis .
No single country outside the U.S. contributed more than 10% of total revenues during the nine months ended September 30, 2017 or 2016 . Our business istypically not seasonal.
GTN Adjustments
The reconciliation of gross product sales to net product sales by each significant category of GTN adjustments was as follows (excluding alliance and otherrevenues such as Atripla* ):
Three Months Ended September 30, Nine Months Ended September 30,
Dollars in Millions 2017 2016 % Change 2017 2016 % ChangeGross product sales $ 6,555 $ 5,698 15% $ 18,723 $ 16,252 15%GTN adjustments: Charge-backs and cash discounts (583) (427) 37% (1,521) (1,174) 30%Medicaid and Medicare rebates (573) (397) 44% (1,474) (1,018) 45%Other rebates, returns, discounts and adjustments (537) (382) 41% (1,516) (1,172) 29%Total GTN adjustments (1,693) (1,206) 40% (4,511) (3,364) 34%Net product sales $ 4,862 $ 4,492 8% $ 14,212 $ 12,888 10%
GTN adjustments percentage 26% 21% 5% 24% 21% 3%
U.S. 32% 26% 6% 30% 26% 4%Non-U.S. 15% 14% 1% 14% 12% 2%
Reductions to provisions for product sales made in prior periods resulting from changes in estimates were $65 million and $143 million in the nine months endedSeptember 30, 2017 and 2016 , respectively. GTN adjustments are primarily a function of product sales volume, regional and payer channel mix, contractual andlegislative discounts and rebates. GTN adjustments are increasing at a higher rate than gross product sales due to higher U.S. Eliquis gross product sales, which hasa relatively high GTN adjustment percentage.
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Product Revenues
Three Months Ended September 30, Nine Months Ended September 30,
Dollars in Millions 2017 2016 % Change 2017 2016 % ChangePrioritized Brands Opdivo $ 1,265 $ 920 38 % $ 3,587 $ 2,464 46 %
U.S. 778 712 9 % 2,307 1,949 18 %Non-U.S. 487 208 ** 1,280 515 **
Eliquis 1,232 884 39 % 3,509 2,395 47 %
U.S. 717 512 40 % 2,119 1,424 49 %Non-U.S. 515 372 38 % 1,390 971 43 %
Orencia 632 572 10 % 1,817 1,640 11 %
U.S. 432 387 12 % 1,243 1,109 12 %Non-U.S. 200 185 8 % 574 531 8 %
Sprycel 509 472 8 % 1,478 1,330 11 %
U.S. 278 259 7 % 806 702 15 %Non-U.S. 231 213 8 % 672 628 7 %
Yervoy 323 285 13 % 975 789 24 %
U.S. 239 222 8 % 727 600 21 %Non-U.S. 84 63 33 % 248 189 31 %
Empliciti 60 41 46 % 168 103 63 %
U.S. 39 36 8 % 112 97 15 %Non-U.S. 21 5 ** 56 6 **
Established Brands Hepatitis C Franchise 73 379 (81)% 347 1,352 (74)%
U.S. 24 192 (88)% 96 745 (87)%Non-U.S. 49 187 (74)% 251 607 (59)%
Baraclude 264 306 (14)% 819 896 (9)%
U.S. 14 17 (18)% 40 49 (18)%Non-U.S. 250 289 (13)% 779 847 (8)%
Sustiva Franchise 183 275 (33)% 555 819 (32)%
U.S. 157 234 (33)% 471 689 (32)%Non-U.S. 26 41 (37)% 84 130 (35)%
Reyataz Franchise 174 238 (27)% 555 706 (21)%
U.S. 85 125 (32)% 260 367 (29)%Non-U.S. 89 113 (21)% 295 339 (13)%
Other Brands 539 550 (2)% 1,517 1,690 (10)%
U.S. 101 94 7 % 286 284 1 %Non-U.S. 438 456 (4)% 1,231 1,406 (12)%
** Change in excess of 100%
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Opdivo (nivolumab) — a fully human monoclonal antibody that binds to the PD-1 on T and NKT cells that has been approved for several anti-cancer indicationsincluding bladder, blood, colon, head and neck, kidney, liver, lung, melanoma and stomach and continues to be investigated across other tumor types and diseaseareas.• U.S. revenues increased in both periods due to higher demand. We expect increased competition for Opdivo to continue in the future.• International revenues increased in both periods due to higher demand as a result of launches of additional indications and approvals in new countries.
Eliquis (apixaban) — an oral Factor Xa inhibitor, targeted at stroke prevention in adult patients with non-valvular atrial fibrillation and the prevention andtreatment of venous thromboembolic disorders.• U.S. and international revenues increased in both periods due to higher demand resulting from increased commercial acceptance of novel oral anticoagulants
and market share gains.
Orencia (abatacept) — a fusion protein indicated for adult patients with moderate to severe active RA and PsA and is also indicated for reducing signs andsymptoms in certain pediatric patients with moderately to severely active polyarticular juvenile idiopathic arthritis.• U.S. revenues increased in both periods due to higher average net selling prices and demand.• International revenues increased in both periods due to higher demand.
Sprycel (dasatinib) — an oral inhibitor of multiple tyrosine kinase indicated for the first-line treatment of adults with Philadelphia chromosome-positive chronicmyeloid leukemia in chronic phase and the treatment of adults with chronic, accelerated, or myeloid or lymphoid blast phase CML with resistance or intolerance toprior therapy, including Gleevec* (imatinib meslylate).• U.S. revenues increased in both periods primarily due to higher demand.• International revenues increased in both periods due to higher demand.
Yervoy (ipilimumab) — a monoclonal antibody for the treatment of patients with unresectable or metastatic melanoma.• U.S. revenues increased in both periods primarily due to higher demand.• International revenues increased in both periods due to higher demand.
Empliciti (elotuzumab) — a humanized monoclonal antibody for the treatment of multiple myeloma.
• Empliciti was launched in the U.S. in December 2015, in the EU in May 2016 and in Japan in September 2016.
Hepatitis C Franchise — Daklinza (daclatasvir) - an NS5A replication complex inhibitor; Sunvepra (asunaprevir) - an NS3 protease inhibitor; and beclabuvir - anNS5B inhibitor. Includes Ximency , a single pill combination of daclatasvir, asunaprevir and beclabuvir in Japan.• U.S. and international revenues decreased in both periods due to lower demand resulting from increased competition.
Baraclude (entecavir) — an oral antiviral agent for the treatment of chronic hepatitis B.• International revenues continued to decrease in both periods due to lower demand resulting from increased competition.
Sustiva (efavirenz) Franchise — a non-nucleoside reverse transcriptase inhibitor for the treatment of HIV, which includes Sustiva , an antiretroviral drug, and bulkefavirenz, which is also included in the combination therapy, Atripla*.• U.S. revenues continued to decrease in both periods due to lower demand resulting from increased competition. The loss of exclusivity for Sustiva is expected
in December 2017 which may result in the termination of the joint venture agreement with Gilead and further reduce revenues beyond 2017.
Reyataz (atazanavir sulfate) Franchise — Includes Reyataz - a protease inhibitor for the treatment of HIV and Evotaz (atazanavir 300 mg and cobicistat 150 mg) -a combination therapy containing Reyataz and Tybost* (cobicistat).• U.S. revenues continued to decrease due to lower demand resulting from increased competition. The loss of exclusivity is expected in December 2017 and will
result in a higher decline in revenues in future periods due to generic competition.• International revenues continued to decrease in both periods due to lower demand.
Other Brands — includes all other products, including those which have lost exclusivity in major markets, OTC brands and royalty revenue.• International revenues decreased in both periods due to out-licensing and divestiture of certain other brands and continued generic erosion.
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Estimated End-User Demand
Pursuant to the SEC Consent Order described in our 2016 Annual Report on Form 10-K, we monitor inventory levels on hand in the U.S. wholesaler distributionchannel and outside of the U.S. in the direct customer distribution channel. We are obligated to disclose products with levels of inventory in excess of one monthon hand or expected demand, subject to a de minimis exception. Estimated levels of inventory in the distribution channel in excess of one month on hand for thefollowing products were not material to our results of operations as of the dates indicated. No U.S. products had estimated levels of inventory in the distributionchannel in excess of one month on hand at September 30, 2017 . Below are international products that had estimated levels of inventory in the distribution channelin excess of one month at June 30, 2017 .
Dafalgan , an analgesic product sold principally in Europe, had 1.2 months of inventory on hand internationally at direct customers compared to 1.3months of inventory on hand at March 31, 2017. The level of inventory on hand was primarily due to the ordering patterns of pharmacists in France.
Fervex , a cold and flu product, had 4.0 months of inventory on hand at direct customers compared to 2.7 months of inventory on hand at March 31, 2017.The level of inventory on hand was attributable to France to support product seasonality.
Perfalgan , an analgesic product, had 1.5 months of inventory on hand internationally at direct customers compared to 1.6 months of inventory on hand atMarch 31, 2017. The level of inventory on hand was due to extended delivery lead time primarily in the Gulf Countries.
Sunvepra , a Hepatitis C product, had 1.1 months of inventory on hand at direct customers compared to 1.1 months of inventory on hand at March 31,2017. The level of inventory on hand was attributable to decreasing in-market sales primarily in Japan.
Ximency , a Hepatitis C product, had 1.1 months of inventory on hand at direct customers compared to 2.4 months of inventory on hand at March 31,2017. The product was launched in February 2017 in Japan.
In the U.S., we generally determine our months on hand estimates using inventory levels of product on hand and the amount of out-movement provided by ourthree largest wholesalers and our distributors. Our three largest wholesalers account for approximately 95% of total gross sales of U.S. products. Factors that mayinfluence our estimates include generic competition, wholesaler purchases in light of increases in wholesaler list prices, new product launches, new warehouseopenings by wholesalers and new customer stockings by wholesalers. In addition, these estimates are calculated using third-party data, which may be impacted bytheir recordkeeping processes.
Our non-U.S. businesses have significantly more direct customers. Information on available direct customer product level inventory and corresponding out-movement information and the reliability of third-party demand information varies widely. We limit our direct customer sales channel inventory reporting to wherewe can influence demand. When this information does not exist or is otherwise not available, we have developed a variety of methodologies to estimate such data,including using historical sales made to direct customers and third-party market research data related to prescription trends and end-user demand. Given thedifficulties inherent in estimating third-party demand information, we evaluate our methodologies to estimate direct customer product level inventory and tocalculate months on hand on an ongoing basis and make changes as necessary. Factors that may affect our estimates include generic competition, seasonality ofproducts, price increases, new product launches, new warehouse openings by direct customers, new customer stockings by direct customers and expected directcustomer purchases for governmental bidding situations. As a result, all of the information required to estimate months on hand in the direct customer distributionchannel for non-U.S. businesses for the quarter ended September 30, 2017 is not available prior to the filing of this quarterly report on Form 10-Q. We will discloseany product with inventory levels in excess of one month on hand or expected demand for the current quarter, subject to a de minimis exception, in the next annualreport on Form 10-K.
Expenses
Three Months Ended September 30, Nine Months Ended September 30,
Dollars in Millions 2017 2016 % Change 2017 2016 % ChangeCost of products sold $ 1,572 $ 1,305 20 % $ 4,393 $ 3,563 23 %Marketing, selling and administrative 1,147 1,144 — 3,388 3,450 (2)%Research and development 1,543 1,138 36 % 4,490 3,540 27 %Other (income)/expense (191) (224) (15)% (1,377) (1,198) 15 %Total Expenses $ 4,071 $ 3,363 21 % $ 10,894 $ 9,355 16 %
Cost of products sold increased in both periods due to higher Eliquis profit sharing (approximately $150 million and $520 million for the three and nine monthsended September 30, 2017 , respectively) and higher inventory charges, including a $70 million charge resulting from lower expected HCV demand requirements.The nine months ended September 30, 2017 also included a $128 million impairment charge to reduce the carrying value of assets held-for-sale to their estimatedfair value. Refer to "Item 1. Financial Statements—Note 4 . Acquisitions, Divestitures and Licensing Arrangements" for further information.
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Research and development expense increased in both periods due to higher license and asset acquisition charges, accelerated depreciation and the expansion ofOpdivo development programs. The nine months ended September 30, 2017 also included higher IPRD impairment charges.
The significant license and asset acquisition transactions and other charges included in R&D expense were as follows:
Three Months Ended September 30, Nine Months Ended September 30,
Dollars in Millions 2017 2016 2017 2016
IFM $ 310 $ — $ 310 $ —CytomX — — 200 10Flexus — — 93 100Cardioxyl — — 100 —Padlock — — — 139Cormorant — 35 — 35Other — 10 50 25
License and asset acquisition charges 310 45 753 309IPRD impairments — — 75 —Accelerated depreciation and other 64 14 232 40
• License and asset acquisition charges include upfront payments for the IFM, CytomX, Padlock and Cormorant arrangements and milestone payments forthe CytomX, Flexus and Cardioxyl arrangements. These arrangements were related to certain investigational oncology, cardiovascular andimmunoscience compounds.
• IPRD impairment charges in the nine months ended September 30, 2017 related to the discontinued development of an investigational compound whichwas part of our alliance with F-Star Alpha.
• Accelerated depreciation and other charges resulted from the expected exit of R&D sites in the U.S. through 2020 primarily due to the reduction in theestimated useful lives of the related assets for each site.
Refer to "Item 1. Financial Statements—Note 3 . Alliances, Note 4 . Acquisitions, Divestitures and Licensing Arrangements and Note 6 . Restructuring" for furtherinformation.
Other income increased in the nine months ended September 30, 2017 due to higher royalties and licensing income and litigation and other settlement incomepartially offset by lower divestiture gains and transition and other service fees and higher restructuring charges. The significant changes included in other incomewere as follows:
Three Months Ended September 30, Nine Months Ended September 30,
Dollars in Millions 2017 2016 2017 2016
Provision for restructuring $ 28 $ 19 $ 207 $ 41Litigation and other settlements — (1) (489) 48Divestiture (gains)/losses 1 (21) (126) (574)Royalties and licensing income (209) (158) (1,093) (579)Transition and other service fees (12) (57) (32) (184)
• Restructuring charges relate to changes to the Company's operating model to drive continued success in the near- and long-term through a more focusedinvestment in commercial opportunities for key brands and markets, a competitive and more agile R&D organization that can accelerate the pipeline,streamline operations and realign manufacturing capabilities that broaden biologics capabilities to reflect the current and future portfolio as well asstreamline and simplify our small-molecule supply network. The new operating model is expected to enable the Company to deliver the strategic,financial and operational flexibility necessary to invest in the highest priorities across the Company. Aggregate restructuring charges of approximately$250 million are expected to be incurred in 2017 for all actions in addition to accelerated depreciation impacts resulting from early site exits.
• Litigation and other settlements include BMS's share of a patent-infringement litigation settlement related to Merck's PD-1 antibody Keytruda* in the firstquarter of 2017 as BMS and Ono signed a global patent license agreement with Merck. Merck made an initial payment of $625 million to BMS and Ono,of which BMS received $481 million. Merck is also obligated to pay ongoing royalties on global sales of Keytruda* of 6.5% from January 1, 2017through December 31, 2023, and 2.5% from January 1, 2024 through December 31, 2026. The companies also granted certain rights to each other undertheir respective
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patent portfolios pertaining to PD-1. Payments and royalties are shared between BMS and Ono on a 75/25 percent allocation, respectively after adjustingfor each parties' legal fees.
• Divestiture gains include additional contingent consideration for the diabetes business ($100 million) in the first quarter of 2017, an OTC product businessin the second quarter of 2016 ($277 million) and the investigational HIV medicines business in the first quarter of 2016 ($272 million).
• Royalties and licensing income include upfront licensing fees from Biogen ($300 million) and Roche ($170 million) in the second quarter of 2017 inconnection with the out-licensing of certain investigational genetically defined disease compounds.
• Transition and other service fees in 2016 included fees resulting from the divestiture of the diabetes business in 2014 and the investigational HIVmedicines business in 2016.
Refer to "Item 1. Financial Statements—Note 4 . Acquisitions, Divestitures and Licensing Arrangements, Note 5 . Other (Income)/Expense, Note 6 . Restructuringand Note 9 . Financial Instruments and Fair Value Measurements" for further information.
Income Taxes
Three Months Ended September 30, Nine Months Ended September 30,
Dollars in Millions 2017 2016 2017 2016Earnings Before Income Taxes $ 1,183 $ 1,559 $ 4,433 $ 4,829Provision for Income Taxes 327 344 1,129 1,220Effective Tax Rate 27.6% 22.1% 25.5% 25.3%
The jurisdictional tax rates and other tax impacts attributed to R&D charges, divestiture transactions and other specified items increased the effective tax rate by3.7% and 3.1% in the nine months ended September 30, 2017 and 2016 , respectively. In addition, the adoption of amended income tax accounting guidancereduced the effective tax rate by 2.1% in the nine months ended September 30, 2017 which was offset by earnings mix between high and low tax jurisdictions.Refer to "Item 1. Financial Statements—Note 1 . Basis of Presentation and Recently Issued Accounting Standards and Note 7 . Income Taxes" for furtherinformation.
Comprehensive U.S. tax reform continues to be discussed and proposed, including among other items, changes to the corporate tax rate, a border adjustment taxand changes to how the U.S. taxes foreign earnings. It is currently uncertain whether any of these changes will be enacted, and if so, the effective dates. Ifcomprehensive tax reform occurs, our financial condition, results of operations and cash flows could be significantly impacted, however, we are unable todetermine the potential impact at this time.
Non-GAAP Financial Measures
Our non-GAAP financial measures, including non-GAAP earnings and related EPS information, are adjusted to exclude certain costs, expenses, gains and lossesand other specified items that are evaluated on an individual basis. These items are adjusted after considering their quantitative and qualitative aspects and typicallyhave one or more of the following characteristics, such as being highly variable, difficult to project, unusual in nature, significant to the results of a particularperiod or not indicative of future operating results. Similar charges or gains were recognized in prior periods and will likely reoccur in future periods includingrestructuring costs, accelerated depreciation and impairment of property, plant and equipment and intangible assets, R&D charges in connection with theacquisition or licensing of third-party intellectual property rights, divestiture and debt redemption gains or losses, pension charges and legal and other contractualsettlements, among other items. Deferred and current income taxes attributed to these items are also adjusted for considering their individual impact to the overalltax expense, deductibility and jurisdictional tax rates.
Non-GAAP information is intended to portray the results of our baseline performance, supplement or enhance management, analysts and investors overallunderstanding of our underlying financial performance and facilitate comparisons among current, past and future periods. For example, non-GAAP earnings andEPS information is an indication of our baseline performance before items that are considered by us to not be reflective of our ongoing results. In addition, thisinformation is among the primary indicators we use as a basis for evaluating performance, allocating resources, setting incentive compensation targets and planningand forecasting for future periods. This information is not intended to be considered in isolation or as a substitute for net earnings or diluted EPS prepared inaccordance with GAAP.
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Specified items were as follows:
Three Months Ended September 30, Nine Months Ended September
30,
Dollars in Millions 2017 2016 2017 2016Impairment charges $ 1 $ — $ 128 $ —Accelerated depreciation and other shutdown costs — 7 3 15Cost of products sold 1 7 131 15 License and asset acquisition charges 310 45 753 309IPRD impairments — — 75 —Accelerated depreciation and other 64 14 232 40Research and development 374 59 1,060 349 Provision for restructuring 28 19 207 41Litigation and other settlements — (3) (481) 40Divestiture gains — (13) (100) (559)Royalties and licensing income — — (497) —Pension charges 22 19 91 66Intangible asset impairments — — — 15Loss on debt redemption — — 109 —Other (income)/expense 50 22 (671) (397) Increase/(decrease) to pretax income 425 88 520 (33)Income taxes on specified items (41) (3) 51 156Increase to net earnings 384 85 571 123Noncontrolling interest — — (59) —Increase to net earnings used for Diluted Non-GAAP EPS calculation $ 384 $ 85 $ 512 $ 123
The reconciliations from GAAP to Non-GAAP were as follows:
Three Months Ended September 30, Nine Months Ended September 30,
Dollars in Millions, except per share data 2017 2016 2017 2016Net Earnings Attributable to BMS used for Diluted EPS Calculation – GAAP $ 845 $ 1,202 $ 3,335 $ 3,563Specified Items 384 85 512 123Net Earnings used for Diluted EPS Calculation – Non-GAAP $ 1,229 $ 1,287 $ 3,847 $ 3,686
Average Common Shares Outstanding – Diluted 1,645 1,679 1,655 1,679 Diluted Earnings Per Share – GAAP $ 0.51 $ 0.72 $ 2.02 $ 2.12Diluted EPS Attributable to Specified Items 0.24 0.05 0.30 0.08Diluted Earnings Per Share – Non-GAAP $ 0.75 $ 0.77 $ 2.32 $ 2.20
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FINANCIAL POSITION, LIQUIDITY, AND CAPITAL RESOURCES
Our net cash position was as follows:
Dollars in MillionsSeptember 30,
2017 December 31,
2016Cash and cash equivalents $ 4,644 $ 4,237Marketable securities – current 2,478 2,113Marketable securities – non-current 2,526 2,719Cash, cash equivalents and marketable securities 9,648 9,069Short-term debt obligations (1,461) (992)Long-term debt (6,982) (5,716)Net cash position $ 1,205 $ 2,361
Cash, cash equivalents and marketable securities held in the U.S. were approximately $200 million at September 30, 2017 . Most of the remaining $9.4 billion isheld primarily in low-tax jurisdictions attributable to earnings expected to be indefinitely reinvested offshore. Cash repatriations are subject to restrictions in certainjurisdictions and may be subject to withholding and additional U.S. income taxes. We believe that our existing cash, cash equivalents and marketable securitiestogether with cash generated from operations and issuance of commercial paper in the U.S. will be sufficient to satisfy our normal cash requirements for at least thenext few years, including dividends, capital expenditures, milestone payments, working capital and maturities of long-term debt.
Management continuously evaluates the Company’s capital structure to ensure the Company is financed efficiently, which may result in the repurchase of commonstock and debt securities, termination of interest rate swap contracts prior to maturity and issuance of debt securities.
The Company repurchased $2.2 billion of common stock in 2017 through accelerated share repurchase agreements, Rule 10b5-1 plans and open market purchases.The stock repurchases were funded by $1.5 billion of new long-term debt and cash. The Company repaid $750 million of long-term debt at maturity in the thirdquarter of 2017 and repurchased $337 million of long-term debt in the second quarter of 2017. Refer to “Item 1. Financial Statements—Note 9 . FinancialInstruments and Fair Value Measurements and Note 15 . Equity" for further information.
We issued commercial paper to fund near-term domestic liquidity requirements during 2017. The average amount of commercial paper outstanding was $211million at a weighted-average rate of 1.12% during 2017. The maximum amount of commercial paper outstanding was $1.0 billion with $799 million outstandingat September 30, 2017 .
Dividend payments were $1.9 billion in each of the nine months ended September 30, 2017 and 2016 . Dividends declared per common share were $1.17 and $1.14in the nine months ended September 30, 2017 and 2016 , respectively. Dividend decisions are made on a quarterly basis by our Board of Directors. Annual capitalexpenditures were $1.2 billion in 2016 and are expected to be approximately $1.0 billion in 2017 and $900 million in 2018. We continue to expand our biologicsmanufacturing capabilities and other facility-related activities. For example, we are constructing a new large-scale biologics manufacturing facility in Ireland thatwill produce multiple therapies for our growing biologics portfolio when completed in 2019.
Our investment portfolio includes non-current marketable securities, which are subject to changes in fair value as a result of interest rate fluctuations and othermarket factors. Our investment policy establishes limits on the amount and duration of investments with any institution. The policy also requires that investmentsare only entered into with corporate and financial institutions that meet high credit quality standards. Refer to “Item 1. Financial Statements—Note 9 . FinancialInstruments and Fair Value Measurements” for further information.
We currently have three separate revolving credit facilities totaling $5 billion from a syndicate of lenders. The facilities provide for customary terms and conditionswith no financial covenants. Our 364 day $2.0 billion facility expires in March 2018 and our two $1.5 billion facilities were extended to October 2021 and July2022. Our two $1.5 billion, five-year facilities are extendable annually by one year on the anniversary date with the consent of the lenders. No borrowings wereoutstanding under any revolving credit facility at September 30, 2017 or December 31, 2016 .
Additional regulations in the U.S. could be passed in the future including additional healthcare reform initiatives, comprehensive tax reform, additional pricinglaws and potential importation restrictions which may reduce our results of operations, operating cash flow, liquidity and financial flexibility. We continue tomonitor the potential impact of the economic conditions in certain European and other countries and the related impact on prescription trends, pricing discounts andcreditworthiness of our customers. We believe these economic conditions will not have a material impact on our liquidity, cash flow or financial flexibility.
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Credit Ratings
BMS's long-term and short-term credit ratings assigned by Moody's Investors Service are A2 and Prime-1, respectively, with a negative long-term credit outlook.BMS's long-term and short-term credit ratings assigned by Standard & Poor's are A+ and A-1+, respectively, with a stable long-term credit outlook. BMS's long-term and short-term credit ratings assigned by Fitch are A- and F2, respectively, with a stable long-term credit outlook. Our long-term ratings reflect the agencies'opinion that we have a low default risk but are somewhat susceptible to adverse effects of changes in circumstances and economic conditions. Our short-termratings reflect the agencies' opinion that we have good to extremely strong capacity for timely repayment. Any credit rating downgrade may affect the interest rateof any debt we may incur, the fair market value of existing debt and our ability to access the capital markets generally.
Cash FlowsThe following is a discussion of cash flow activities:
Nine Months Ended September 30,
Dollars in Millions 2017 2016Cash flow provided by/(used in):
Operating activities $ 4,158 $ 1,615Investing activities (1,085) 1,464Financing activities (2,725) (2,048)
Operating ActivitiesCash flow from operating activities represents the cash receipts and disbursements from all of our activities other than investing and financing activities. Operatingcash flow is derived by adjusting net earnings for noncontrolling interest, non-cash operating items, gains and losses attributed to investing and financing activitiesand changes in operating assets and liabilities resulting from timing differences between the receipts and payments of cash and when the transactions arerecognized in our results of operations. As a result, changes in cash from operating activities reflect the timing of cash collections from customers and alliancepartners; payments to suppliers, alliance partners and employees; customer discounts and rebates; and tax payments in the ordinary course of business. Forexample, annual employee bonuses are typically paid in the first quarter of the subsequent year. In addition, cash collections continue to be impacted by longerpayment terms for certain biologic products in the U.S., primarily our newer oncology products including Opdivo , Yervoy and Empliciti (120 days to 150 days).The longer payment terms are used to more closely align with the insurance reimbursement timing for physicians and cancer centers following administration tothe patients.
The $2.5 billion change in cash flow from operating activities compared to 2016 was primarily attributable to the following items in addition to increased sales andthe timing of cash collections and payments in the ordinary course of business:
• Lower income tax payments of approximately $1.4 billion;• Higher out-license proceeds of approximately $500 million primarily related to the Biogen and Roche transactions; and• BMS's share of litigation settlement proceeds of $481 million related to Merck's PD-1 antibody Keytruda*.Partially offset by:• Higher R&D licensing payments of approximately $300 million primarily due to the CytomX transaction.
Investing Activities
Cash requirements from investing activities include cash used for acquisitions, manufacturing and facility-related capital expenditures and purchases of marketablesecurities with maturities greater than 90 days reduced by proceeds from business divestitures (including royalties) and the sale and maturity of marketablesecurities.
The $2.5 billion change in cash flow from investing activities compared to 2016 was primarily attributable to:• Lower net sales of marketable securities with maturities greater than 90 days of $1.6 billion due to higher available cash balances;• Lower business divestiture proceeds of approximately $700 million primarily due to certain OTC products and investigational HIV business divestitures
in 2016; and• Higher asset acquisition payments of approximately $400 million primarily due to the acquisition of IFM in 2017.
Financing Activities
Cash requirements from financing activities include cash used to pay dividends, repurchase common stock and repay long-term debt and other borrowings reducedby proceeds from the exercise of stock options and issuance of long-term debt and other borrowings.
The $677 million change in cash flow from financing activities compared to 2016 was primarily attributable to:• Higher repurchase of common stock of $2.0 billion primarily due to the accelerated share repurchase agreements.Partially offset by:• Higher net borrowings of $1.4 billion primarily to fund the repurchase of common stock.
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Product and Pipeline DevelopmentsWe manage our R&D programs on a portfolio basis, investing resources in each stage from early discovery through late-stage development. We continuallyevaluate our portfolio of R&D assets to ensure that there is an appropriate balance of early- and late-stage programs to support future growth. We consider ourR&D programs that have entered into Phase III development to be significant, as these programs constitute our late-stage development pipeline. These programsinclude both investigational compounds in Phase III development for initial indications and marketed products in Phase III development for additional indicationsor formulations. The following are the recent developments in our marketed products and our late-stage pipeline:
Product Indication Date Developments
Opdivo
Gastric September 2017 Approval in Japan for the treatment of unresectable advanced or recurrent gastric cancer which has progressedafter chemotherapy, received by our alliance partner, Ono.
HCC September 2017 FDA approval for the treatment of patients with HCC, a type of liver cancer, who have been previously treatedwith sorafenib.
mCRC August 2017 FDA approval for the treatment of adult and pediatric patients with MSI-H or dMMR mCRC that hasprogressed following treatment with a fluoropyrimidine, oxaliplatin and irinotecan.
Melanoma
October 2017Announced FDA accepted for priority review the Company's sBLA for Opdivo to treat patients with melanomawho are at high risk of disease recurrence following complete surgical resection. The FDA action date isFebruary 14, 2018.
September 2017 Announced treatment with Opdivo resulted in significant improvement in recurrence-free survival compared toYervoy in patients with stage IIIb/c or stage IV melanoma following complete surgical resection.
July 2017Announced a Phase III trial evaluating Opdivo versus Yervoy in patients with stage IIIb/c or stage IVmelanoma who are at high risk of recurrence following complete surgical resection met its primary endpoint ofrecurrence-free survival at a planned interim analysis.
Multiple Myeloma September 2017
Announced the FDA placed a partial clinical hold on CheckMate-602, CheckMate-039 and CA204142, threeclinical trials investigating Opdivo based combinations in patients with relapsed or refractory multiplemyeloma. This partial clinical hold is related to risks identified in trials studying another anti-PD-1 agent,pembrolizumab, in patients with multiple myeloma.
NSCLC September 2017 Announced three-year overall survival data from CheckMate-017 and CheckMate-057, two pivotal Phase IIIrandomized studies evaluating Opdivo vs. docetaxel in patients with previously treated metastatic NSCLC.
Various July 2017
BMS and Clovis Oncology, Inc. announced a clinical collaboration to evaluate the combination of Opdivo andRubraca* (rucaparib) in pivotal Phase III trials in advanced ovarian cancer and triple-negative breast cancer aswell as a Phase II trial in metastatic castration-resistant prostate cancer.
Announced FDA accepted the Company's sBLAs to update Opdivo dosing to include 480 mg infused over 30minutes every four weeks for all currently approved monotherapy indications. The FDA action date is March 5,2018.
Opdivo+YervoyRCC
September 2017
Announced CheckMate-214, a Phase III study evaluating Opdivo+Yervoy versus sunitinib in patients withpreviously untreated advanced or metastatic RCC, met its co-primary endpoint, demonstrating superior overallsurvival in intermediate- and poor-risk patients. The combination also met a secondary endpoint of improvedOS in all randomized patients. Based on a planned interim analysis, an independent Data Monitoring Committeehas recommended that the trial be stopped early.
August 2017Announced topline results from CheckMate-214. The combination of Opdivo + Yervoy met the co-primaryendpoint of objective response rate and was favored in the co-primary endpoint of progression-free survival,however, it did not reach statistical significance.
July 2017BMS and Exelixis, Inc. announced the initiation of the Phase III CheckMate 9ER trial to evaluate Opdivo incombination with Cabometyx* (cabozantinib) or Opdivo and Yervoy in combination with Cabometyx* versussunitinib in patients with previously untreated, advanced or metastatic RCC.
SCLC October 2017 Announced data evaluating Opdivo and Opdivo+Yervoy in previously treated SCLC patients whose tumorswere evaluable for tumor mutation burden from the Phase I/II CheckMate-032 trial.
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Product Indication Date Developments
Eliquis NVAF August 2017
Announced results from a real-world data analysis of the U.S. Humana database, in which treatment withEliquis was associated with a significantly lower risk of stroke/systemic embolism and lower rates of majorbleeding compared to warfarin in patients aged 65 years and older with NVAF.
Announced data from EMANATE, a Phase IV trial, exploring the safety and efficacy of Eliquis in patients withNVAF undergoing cardioversion.
Announced results from a real-world data analysis pooled from four large U.S. insurance claims databases, inwhich treatment with Eliquis was associated with a lower risk of stroke/systemic embolism and lower rates ofmajor bleeding compared to warfarin for the overall population and for each of the selected high-risk patientsub-populations.
Orencia PsA July 2017
EC approval for the treatment of active PsA in adults for whom the response to previous disease-modifyingantirheumatic drug therapy, including methotrexate, has been inadequate, and additional systemic therapy forpsoriatic skin lesions is not required.
FDA approval for active PsA in adults, a chronic, inflammatory disease that can affect both the skin andmusculoskeletal system.
Sprycel CML July 2017Announced the FDA accepted for priority review a supplemental NDA to treat children with Philadelphiachromosome-positive chronic phase CML, as well as a powder for oral suspension formulation of Sprycel . TheFDA action date is November 9, 2017.
Yervoy MelanomaOctober 2017
Announced the FDA added five-year overall survival data from the Phase III CA184-029 trial to the prescribinginformation for Yervoy for the adjuvant treatment of fully resected cutaneous melanoma with pathologicinvolvement of regional lymph nodes of more than 1 mm.
July 2017 FDA approval of an expanded indication for the treatment of unresectable or metastatic melanoma in pediatricpatients.
Prostvac* Prostate Cancer September 2017Bavarian Nordic A/S announced an independent Data Monitoring Committee determined that the continuationof the Phase III PROSPECT study of Prostvac* in patients with metastatic castration-resistant prostate canceris futile.
CRITICAL ACCOUNTING POLICIES
The preparation of financial statements requires the use of estimates and assumptions that affect the reported amounts of assets and liabilities and the reportedamounts of revenue and expenses. Our critical accounting policies are those that significantly impact our financial condition and results of operations and requirethe most difficult, subjective or complex judgments, often as a result of the need to make estimates about the effect of matters that are inherently uncertain.Because of this uncertainty, actual results may vary from these estimates. For a discussion of our critical accounting policies, refer to “Item 7. Management’sDiscussion and Analysis of Financial Condition and Results of Operations” in our 2016 Annual Report on Form 10-K. There have been no material changes to ourcritical accounting policies during the nine months ended September 30, 2017 .
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This quarterly report on Form 10-Q (including documents incorporated by reference) and other written and oral statements we make from time to time containcertain “forward-looking” statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934.You can identify these forward-looking statements by the fact they use words such as “should”, “expect”, “anticipate”, “estimate”, “target”, “may”, “project”,“guidance”, “intend”, “plan”, “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating orfinancial performance. One can also identify forward-looking statements by the fact that they do not relate strictly to historical or current facts. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them,and could cause actual outcomes to differ materially from current expectations. These statements are likely to relate to, among other things, our goals, plans andprojections regarding our financial position, results of operations, cash flows, market position, product development, product approvals, sales efforts, expenses,performance or results of current and anticipated products and the outcome of contingencies such as legal proceedings and financial results, which are based oncurrent expectations that involve inherent risks and uncertainties, including internal or external factors that could delay, divert or change any of them in the nextseveral years. We have included important factors in the cautionary statements included in this report and in the 2016 Annual Report on Form 10-K, particularlyunder “Item 1A. Risk Factors,” that we believe could cause actual results to differ materially from any forward-looking statement.
Although we believe we have been prudent in our plans and assumptions, no assurance can be given that any goal or plan set forth in forward-looking statementscan be achieved and readers are cautioned not to place undue reliance on such statements, which speak only as of the date made. We undertake no obligation torelease publicly any revisions to forward-looking statements as a result of new information, future events or otherwise.
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Item 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
For a discussion of our market risk, refer to “Item 7A. Quantitative and Qualitative Disclosures About Market Risk” in our 2016 Annual Report on Form 10-K.
Item 4. CONTROLS AND PROCEDURES
Management, with the participation of the Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls andprocedures. Based on their evaluation, as of the end of the period covered by this Form 10-Q, the Chief Executive Officer and Chief Financial Officer haveconcluded that such disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934) are effective.
There were no changes in the Company’s internal control over financial reporting during the quarter ended September 30, 2017 that have materially affected, or arereasonably likely to materially affect, the Company’s internal control over financial reporting.
PART II—OTHER INFORMATION
Item 1. LEGAL PROCEEDINGS
Information pertaining to legal proceedings can be found in “Item 1. Financial Statements—Note 17 . Legal Proceedings and Contingencies,” to the interimconsolidated financial statements, and is incorporated by reference herein.
Item 1A. RISK FACTORS
There have been no material changes from the risk factors disclosed in the Company’s 2016 Annual Report on Form 10-K.
Item 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
The following table summarizes the surrenders of our equity securities during the three months ended September 30, 2017 :
PeriodTotal Number of
Shares Purchased (a)
Average Price Paid
per Share (a)
Total Number of Shares Purchased as
Part of PubliclyAnnounced
Programs (b)
Approximate Dollar Value of Shares that
May Yet BePurchased Under the
Programs (b)
Dollars in Millions, Except Per Share Data July 1 to 31, 2017 63,794 $ 56.63 52,851 $ 2,134August 1 to 31, 2017 2,994,306 $ 57.68 2,985,959 $ 1,962September 1 to 30, 2017 812,937 $ 62.53 803,249 $ 1,912
Three months ended September 30, 2017 3,871,037 3,842,059 (a) Includes shares repurchased as part of publicly announced programs and shares of common stock surrendered to the Company to satisfy tax withholding obligations in connection with
the vesting of awards under our long-term incentive program.(b) In May 2010, the Board of Directors authorized the repurchase of up to $3.0 billion of common stock and in June 2012 increased its authorization for the repurchase of common stock by
an additional $3.0 billion. In October 2016, the Board of Directors approved a new share repurchase program authorizing the repurchase of an additional $3.0 billion of common stock.The stock repurchase program does not have an expiration date. Refer to “Item 1. Financial Statements—Note 15 . Equity" for information on the accelerated share repurchaseagreements.
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Item 6. EXHIBITS
Exhibits (listed by number corresponding to the Exhibit Table of Item 601 in Regulation S-K).
Exhibit No. Description12. Computation of Earnings to Fixed Charges.31a. Section 302 Certification Letter.31b. Section 302 Certification Letter.32a. Section 906 Certification Letter.32b. Section 906 Certification Letter.101.
The following financial statements from the Bristol-Myers Squibb Company Quarterly Report on Form 10-Q for the quarter endedSeptember 30, 2017, formatted in Extensible Business Reporting Language (XBRL):(i) consolidated statements of earnings, (ii) consolidated statements of comprehensive income, (iii) consolidated balance sheets, (iv)consolidated statements of cash flows, and (v) the notes to the consolidated financial statements.
* Indicates, in this Form 10-Q, brand names of products, which are registered trademarks not solely owned by the Company or its subsidiaries. Abilify is atrademark of Otsuka Pharmaceutical Co., Ltd.; Atripla is a trademark of Bristol-Myers Squibb and Gilead Sciences, LLC; Byetta is a trademark of AmylinPharmaceuticals, LLC; Cabometyx is a trademark of Exelixis, Inc.; ENHANZE is a trademark of Halozyme, Inc.; Erbitux is a trademark of ImClone LLC; Gleevecis a trademark of Novartis AG; Keytruda is a trademark of Merck Sharp & Dohme Corp.; Plavix is a trademark of Sanofi; Prostvac is a trademark of BNImmunoTherapeutics Inc.; Rubraca is a trademark of Clovis Oncology, Inc. and Tybost is a trademark of Gilead Sciences Ireland UC. Brand names of productsthat are in all italicized letters, without an asterisk, are registered trademarks of BMS and/or one of its subsidiaries.
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SUMMARY OF ABBREVIATED TERMSBristol-Myers Squibb Company may be referred to as Bristol-Myers Squibb, BMS, the Company, we, our or us in this Quarterly Report on Form 10-Q. Throughoutthis Quarterly Report on Form 10-Q we have used terms which are defined below:
2016 Form 10-K Annual Report on Form 10-K for the fiscal year ended December 31, 2016AstraZeneca AstraZeneca PLCBiogen Biogen Inc.Cardioxyl Cardioxyl Pharmaceuticals, Inc.CML chronic myeloid leukemiaCytomX CytomX Therapeutics, Inc.dMMR DNA mismatch repair deficientEPO European Patent OfficeEPS earnings per shareEU European UnionFASB Financial Accounting Standards BoardFDA U.S. Food and Drug AdministrationFlexus Flexus Biosciences, Inc.F-Star Alpha F-Star Alpha Ltd.GAAP U.S. generally accepted accounting principlesGilead Gilead Sciences, Inc.GTN Gross-to-NetHalozyme Halozyme Therapeutics, Inc.HCC Hepatocellular carcinomaHIV human immunodeficiency virusHNC head and neck cancerIFM IFM Therapeutics, Inc.iPierian iPierian, Inc.IO immuno-oncologyIPRD In-process research and developmentJIA Juvenile Idiopathic ArthritismCRC metastatic colorectal cancerMerck Merck & Co., Inc.MSI-H microsatellite instability-highNDA New Drug ApplicationNKT natural killer T cellsNSCLC non-small cell lung cancerNVAF non-valvular atrial fibrillationOno Ono Pharmaceutical Co., Ltd.OTC Over-the-counterPadlock Padlock Therapeutics, Inc.PD-1 programmed death receptor-1PsA active psoriatic arthritisQuarterly Report on Form 10-Q Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2017RA rheumatoid arthritisRCC renal cell carcinomaR&D Research and DevelopmentsBLA supplemental Biologics License ApplicationSCCHN squamous cell carcinoma of the head and neckSCLC small cell lung cancerSEC Securities and Exchange CommissionSK Biotek SK Biotek Co., Ltd.UK United KingdomU.S. United States
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersignedthereunto duly authorized.
BRISTOL-MYERS SQUIBB COMPANY(REGISTRANT)
Date: October 26, 2017 By: /s/ Giovanni Caforio
Giovanni CaforioChief Executive Officer
Date: October 26, 2017 By: /s/ Charles Bancroft
Charles BancroftChief Financial Officer
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EXHIBIT 12.
Computation of Earnings to Fixed Charges
Ratio of Earnings to Fixed Charges: Nine Months Ended September 30, 2017
Year Ended December 31,
2016 2015 2014 2013
Dollars in Millions Earnings Earnings from continuing operations before income taxes $ 4,433 $ 5,915 $ 2,077 $ 2,381 $ 2,891Less: Noncontrolling interest in pretax income/(loss) of subsidiaries that have not incurred fixed charges (66) 16 51 38 36Equity in net income of affiliates 59 77 83 107 166Capitalized interest 11 10 2 3 —Adjusted Income 4,429 5,812 1,941 2,233 2,689
Add: Fixed charges 187 226 231 254 255Distributed income of equity investments 74 99 105 153 149
Total Earnings $ 4,690 $ 6,137 $ 2,277 $ 2,640 $ 3,093
Fixed Charges Interest expense $ 145 $ 167 $ 184 $ 203 $ 199Capitalized interest 11 10 2 3 —One-third of rental expense (1) 31 49 45 48 56
Total Fixed Charges $ 187 $ 226 $ 231 $ 254 $ 255
Ratio of Earnings to Fixed Charges 25.08 27.15 9.86 10.39 12.13
(1) Rents included in the computation consist of one-third of rental expense which the Company believes to be a reasonable estimate of an interest factor in its leases.
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EXHIBIT 31a.
CERTIFICATION BY THE CHIEF EXECUTIVE OFFICERPURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Giovanni Caforio, certify that:
1. I have reviewed Bristol-Myers Squibb Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2017 ;
2. Based on my knowledge, this quarterly report does not contain any untrue statement of a material fact or omit to state a material fact necessary tomake the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period coveredby this quarterly report;
3. Based on my knowledge, the financial statements, and other financial information included in this quarterly report, fairly present in all materialrespects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this quarterly report;
4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined inExchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined by Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a. designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others withinthose entities, particularly during the period in which this quarterly report is being prepared;
b. designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under oursupervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements forexternal purposes in accordance with generally accepted accounting principles;
c. evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about theeffectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d. disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s mostrecent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likelyto materially affect, the registrant’s internal control over financial reporting;
5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to theregistrant’s auditors and the audit committee of registrant’s board of directors (or persons performing the equivalent function):
a. all significant deficiencies and material weaknesses in the design or operation of internal controls over financial reporting, which arereasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b. any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internalcontrols over financial reporting.
Date: October 26, 2017
/s/ Giovanni CaforioGiovanni CaforioChief Executive Officer
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EXHIBIT 31b.
CERTIFICATION BY THE CHIEF FINANCIAL OFFICERPURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Charles Bancroft, certify that:
1. I have reviewed Bristol-Myers Squibb Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2017 ;
2. Based on my knowledge, this quarterly report does not contain any untrue statement of a material fact or omit to state a material fact necessary tomake the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period coveredby this quarterly report;
3. Based on my knowledge, the financial statements, and other financial information included in this quarterly report, fairly present in all materialrespects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this quarterly report;
4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined inExchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined by Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a. designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others withinthose entities, particularly during the period in which this quarterly report is being prepared;
b. designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under oursupervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements forexternal purposes in accordance with generally accepted accounting principles;
c. evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about theeffectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d. disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s mostrecent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likelyto materially affect, the registrant’s internal control over financial reporting;
5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to theregistrant’s auditors and the audit committee of registrant’s board of directors (or persons performing the equivalent function):
a. all significant deficiencies and material weaknesses in the design or operation of internal controls over financial reporting, which arereasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b. any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internalcontrols over financial reporting.
Date: October 26, 2017
/s/ Charles BancroftCharles BancroftChief Financial Officer
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EXHIBIT 32a.
Certification by the Chief Executive Officer Pursuant to 18 U. S. C. Section 1350, asAdopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
Pursuant to 18 U.S.C. Section 1350, I, Giovanni Caforio, hereby certify that, to the best of my knowledge, Bristol-Myers Squibb Company’s Quarterly Report onForm 10-Q for the quarter ended September 30, 2017 (the Report), as filed with the Securities and Exchange Commission on October 26, 2017 , fully complieswith the requirements of Section 13(a) or Section 15(d) of the Securities Exchange Act of 1934, as amended, and that the information contained in the Report fairlypresents, in all material respects, the financial condition and results of operations of Bristol-Myers Squibb Company.
/s/ Giovanni CaforioGiovanni CaforioChief Executive Officer
October 26, 2017
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EXHIBIT 32b.
Certification by the Chief Financial Officer Pursuant to 18 U. S. C. Section 1350, asAdopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
Pursuant to 18 U.S.C. Section 1350, I, Charles Bancroft, hereby certify that, to the best of my knowledge, Bristol-Myers Squibb Company’s Quarterly Report onForm 10-Q for the quarter ended September 30, 2017 (the Report), as filed with the Securities and Exchange Commission on October 26, 2017 , fully complieswith the requirements of Section 13(a) or Section 15(d) of the Securities Exchange Act of 1934, as amended, and that the information contained in the Report fairlypresents, in all material respects, the financial condition and results of operations of Bristol-Myers Squibb Company.
/s/ Charles BancroftCharles BancroftChief Financial Officer
October 26, 2017
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